SubjectID Site SubjectStatus Visit VisitRepeatLabel Form FormRepeatLabel FormEntryDate AE_NONE AE_NONE_CODED VarGroup1Row AE_NUMBER AE_NUMBER_CODED AE_DIAGNOSIS AE_DIAGNOSIS_CODED AE_DIAGNOSIS_CODED AE_DIAGNOSIS_LLT AE_DIAGNOSIS_LLTID AE_DIAGNOSIS_PT AE_DIAGNOSIS_PTID AE_DIAGNOSIS_HLT AE_DIAGNOSIS_HLTID AE_DIAGNOSIS_HLGT AE_DIAGNOSIS_HLGTID AE_DIAGNOSIS_SOC AE_DIAGNOSIS_SOCID AE_SERIOUSNESS AE_SERIOUSNESS_CODED AE_DATE_OF_ONSET AE_DATE_OF_ONSET_P AE_DATE_OF_ONSET_CODED AE_DATE_OF_RESOLUTION AE_DATE_OF_RESOLUTION_P AE_DATE_OF_RESOLUTION_CODED AE_SEVERITY AE_SEVERITY_CODED AE_FREQUENCY AE_FREQUENCY_CODED AE_ACTION_TREATMENT AE_ACTION_TREATMENT_CODED AE_ACTION_SPECIFY AE_ACTION_SPECIFY_CODED AE_OUTCOME AE_OUTCOME_CODED AE_RELATIONSHIP_TO_DRUG AE_RELATIONSHIP_TO_DRUG_CODED SubjectVisitFormID 01101 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 9150659 01101 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 Emesis Emesis Emesis 10014542 Vomiting 10047700 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 06-Feb-2017 06-Feb-2017 Severe 3 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9150659 01101 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 Muscle tremor Tremor muscle Tremor muscle 10044573 Tremor 10044565 Tremor (excl congenital) 10044566 Movement disorders (incl parkinsonism) 10028037 Nervous system disorders 10029205 Not Serious 0 06-Feb-2017 06-Feb-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9150659 01101 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 Paranoia Paranoia Paranoia 10033864 Paranoia 10033864 Behaviour and socialisation disturbances 10004209 Personality disorders and disturbances in behaviour 10034726 Psychiatric disorders 10037175 Not Serious 0 06-Feb-2017 06-Feb-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9150659 01101 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 Nausea Nausea Nausea 10028813 Nausea 10028813 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 06-Feb-2017 06-Feb-2017 Severe 3 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9150659 01101 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 Weakness Feelings of weakness Feelings of weakness 10016373 Asthenia 10003549 Asthenic conditions 10003550 General system disorders NEC 10018073 General disorders and administration site conditions 10018065 Not Serious 0 06-Feb-2017 06-Feb-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9150659 01101 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 Exacerbation of Anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 06-Feb-2017 06-Feb-2017 Severe 3 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9150659 01101 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 7 Dizziness Dizziness Dizziness 10013573 Dizziness 10013573 Neurological signs and symptoms NEC 10029306 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 07-Feb-2017 07-Feb-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9150659 01101 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 8 8 Foot pain Foot pain Foot pain 10016974 Pain in extremity 10033425 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 12-Feb-2017 14-Feb-2017 Severe 3 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 9150659 01101 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 9 9 Difficulty Concentrating Concentration impaired Concentration impaired 10010249 Disturbance in attention 10013496 Mental impairment (excl dementia and memory loss) 10027375 Mental impairment disorders 10057167 Nervous system disorders 10029205 Not Serious 0 08-Feb-2017 08-Feb-2017 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9150659 01101 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 10 10 Difficulty Concentrating Concentration impaired Concentration impaired 10010249 Disturbance in attention 10013496 Mental impairment (excl dementia and memory loss) 10027375 Mental impairment disorders 10057167 Nervous system disorders 10029205 Not Serious 0 13-Feb-2017 13-Feb-2017 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9150659 01101 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 11 11 Dizziness Dizziness Dizziness 10013573 Dizziness 10013573 Neurological signs and symptoms NEC 10029306 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 11-Feb-2017 13-Feb-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9150659 01101 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 12 12 Dizziness Dizziness Dizziness 10013573 Dizziness 10013573 Neurological signs and symptoms NEC 10029306 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 15-Feb-2017 15-Feb-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9150659 01101 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 13 13 Light-headedness Light headedness Light headedness 10024461 Dizziness 10013573 Neurological signs and symptoms NEC 10029306 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 21-Feb-2017 24-Feb-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9150659 01101 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 14 14 light-headedness Light headedness Light headedness 10024461 Dizziness 10013573 Neurological signs and symptoms NEC 10029306 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 27-Feb-2017 27-Feb-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9150659 01101 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 16 15 Exacerbation of back pain Back pain aggravated Back pain aggravated 10048412 Back pain 10003988 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 04-Apr-2017 11-Apr-2017 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 9150659 01101 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 17 16 Upper respiratory infection Upper respiratory infection Upper respiratory infection 10046300 Upper respiratory tract infection 10046306 Upper respiratory tract infections 10046309 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 19-Apr-2017 22-Apr-2017 Severe 3 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 9150659 01101 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 18 17 Upper respiratory infection Upper respiratory infection Upper respiratory infection 10046300 Upper respiratory tract infection 10046306 Upper respiratory tract infections 10046309 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 23-Apr-2017 25-Apr-2017 Moderate 2 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 9150659 01102 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 9708345 01102 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 Upper respiratory infection Upper respiratory infection Upper respiratory infection 10046300 Upper respiratory tract infection 10046306 Upper respiratory tract infections 10046309 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 20-Mar-2017 05-Apr-2017 Mild 1 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 9708345 01102 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 2 upper respiratory infection Upper respiratory infection Upper respiratory infection 10046300 Upper respiratory tract infection 10046306 Upper respiratory tract infections 10046309 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 16-Apr-2017 24-Apr-2017 Moderate 2 Continuous 2 Prescription Medication,Non-prescription Medication 4,5 Full Recovery/Return to Baseline 1 Not Related 0 9708345 01103 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 9667659 01103 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 Exacerbation of anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 29-Mar-2017 31-Mar-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9667659 01103 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 Paranoia Paranoia Paranoia 10033864 Paranoia 10033864 Behaviour and socialisation disturbances 10004209 Personality disorders and disturbances in behaviour 10034726 Psychiatric disorders 10037175 Not Serious 0 16-Apr-2017 16-Apr-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9667659 01103 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 Irritability Irritability Irritability 10022998 Irritability 10022998 Emotional and mood disturbances NEC 10014556 Mood disorders and disturbances NEC 10027946 Psychiatric disorders 10037175 Not Serious 0 19-Apr-2017 19-Apr-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 9667659 01103 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 Cough Cough Cough 10011224 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 23-Feb-2017 23-Feb-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9667659 01104 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 9669213 01104 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 nasal congestion Nasal congestion Nasal congestion 10028735 Nasal congestion 10028735 Nasal congestion and inflammations 10028736 Upper respiratory tract disorders (excl infections) 10046304 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 13-Mar-2017 15-Mar-2017 Mild 1 Single/Intermittent 1 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 9669213 01104 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 2 dizziness Dizziness Dizziness 10013573 Dizziness 10013573 Neurological signs and symptoms NEC 10029306 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 25-Apr-2017 25-Apr-2017 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9669213 01104 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 3 exacerbation of anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 25-Apr-2017 25-Apr-2017 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9669213 01104 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 4 dizziness Dizziness Dizziness 10013573 Dizziness 10013573 Neurological signs and symptoms NEC 10029306 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 26-Apr-2017 26-Apr-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9669213 01104 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 5 difficulty concentrating Concentration impaired Concentration impaired 10010249 Disturbance in attention 10013496 Mental impairment (excl dementia and memory loss) 10027375 Mental impairment disorders 10057167 Nervous system disorders 10029205 Not Serious 0 02-May-2017 14-May-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 9669213 01105 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 9669291 01105 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 Throat irritation Throat irritation Throat irritation 10043521 Throat irritation 10043521 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 15-Mar-2017 07-Apr-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9669291 01105 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 Cough Cough Cough 10011224 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 17-Mar-2017 07-Apr-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9669291 01105 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 Upper respiratory infection Upper respiratory infection Upper respiratory infection 10046300 Upper respiratory tract infection 10046306 Upper respiratory tract infections 10046309 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 22-Apr-2017 24-Apr-2017 Mild 1 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 9669291 01105 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 heat exhaustion Heat exhaustion Heat exhaustion 10019332 Heat exhaustion 10019332 Heat injuries (excl thermal burns) 10019338 Injuries by physical agents 10022119 Injury, poisoning and procedural complications 10022117 Not Serious 0 02-May-2017 04-May-2017 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 9669291 01105 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 Foggy dreamlike feeling Foggy feeling in head Foggy feeling in head 10016876 Feeling abnormal 10016322 Feelings and sensations NEC 10068759 General system disorders NEC 10018073 General disorders and administration site conditions 10018065 Not Serious 0 16-May-2017 29-Dec-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 9669291 01105 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 muscle soreness Muscle soreness Muscle soreness 10028332 Myalgia 10028411 Muscle pains 10028323 Muscle disorders 10028302 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 28-May-2017 29-May-2017 Mild 1 Continuous 2 Other (specify) 8 hot shower Full Recovery/Return to Baseline 1 Not Related 0 9669291 01106 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 9710578 01106 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 Headache Headache Headache 10019211 Headache 10019211 Headaches NEC 10019233 Headaches 10019231 Nervous system disorders 10029205 Not Serious 0 30-Mar-2017 30-Mar-2017 Mild 1 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Possibly Related 1 9710578 01106 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 Neck pain Neck pain Neck pain 10028836 Neck pain 10028836 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 07-Apr-2017 14-May-2017 Mild 1 Continuous 2 Procedure or Therapy 1 Full Recovery/Return to Baseline 1 Not Related 0 9710578 01106 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 Sinus Infection Sinus infection Sinus infection 10040745 Sinusitis 10040753 Upper respiratory tract infections 10046309 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 12-May-2017 19-May-2017 Mild 1 Continuous 2 Prescription Medication,Non-prescription Medication 4,5 Full Recovery/Return to Baseline 1 Not Related 0 9710578 01106 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 increased appetite Increased appetite Increased appetite 10021654 Increased appetite 10021654 Appetite disorders 10003022 Appetite and general nutritional disorders 10003018 Metabolism and nutrition disorders 10027433 Not Serious 0 20-May-2017 20-May-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9710578 01107 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 9675015 01107 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 Agitation Agitation Agitation 10001497 Agitation 10001497 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 18-May-2017 18-May-2017 Severe 3 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 9675015 01107 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 Agitation Agitation Agitation 10001497 Agitation 10001497 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 19-May-2017 21-May-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 9675015 01107 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 Exacerbation of anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 18-May-2017 18-May-2017 Severe 3 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 9675015 01107 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 Exacerbation of anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 19-May-2017 21-May-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 9675015 01107 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 Hostility Hostility Hostility 10020400 Hostility 10020400 Behaviour and socialisation disturbances 10004209 Personality disorders and disturbances in behaviour 10034726 Psychiatric disorders 10037175 Not Serious 0 18-May-2017 18-May-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 9675015 01107 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 Back pain Back pain Back pain 10003988 Back pain 10003988 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 03-Jun-2017 04-Jun-2017 Moderate 2 Continuous 2 Non-prescription Medication,Other (specify) 5,8 heating pad and swimming Full Recovery/Return to Baseline 1 Not Related 0 9675015 01107 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 7 increased headache frequency Frequent headaches Frequent headaches 10052403 Headache 10019211 Headaches NEC 10019233 Headaches 10019231 Nervous system disorders 10029205 Not Serious 0 18-Jun-2017 21-Jun-2017 Moderate 2 Continuous 2 Prescription Medication 4 Full Recovery/Return to Baseline 1 Possibly Related 1 9675015 01107 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 8 8 exacerbation of insomnia Insomnia exacerbated Insomnia exacerbated 10022440 Insomnia 10022437 Disturbances in initiating and maintaining sleep 10013510 Sleep disorders and disturbances 10040991 Psychiatric disorders 10037175 Not Serious 0 18-May-2017 18-May-2017 Severe 3 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 9675015 01107 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 9 9 exacerbation of insomnia Insomnia exacerbated Insomnia exacerbated 10022440 Insomnia 10022437 Disturbances in initiating and maintaining sleep 10013510 Sleep disorders and disturbances 10040991 Psychiatric disorders 10037175 Not Serious 0 19-May-2017 21-May-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 9675015 01108 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 9675018 01108 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 Nausea Nausea Nausea 10028813 Nausea 10028813 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 18-Apr-2017 18-Apr-2017 Severe 3 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9675018 01108 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 Dizziness Dizziness Dizziness 10013573 Dizziness 10013573 Neurological signs and symptoms NEC 10029306 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 18-Apr-2017 18-Apr-2017 Severe 3 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9675018 01108 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 Tight Chest Tight chest Tight chest 10043854 Chest discomfort 10008469 Pain and discomfort NEC 10033372 General system disorders NEC 10018073 General disorders and administration site conditions 10018065 Not Serious 0 18-Apr-2017 18-Apr-2017 Severe 3 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9675018 01108 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 Exacerbation of Paranoia Paranoia aggravated Paranoia aggravated 10033865 Paranoia 10033864 Behaviour and socialisation disturbances 10004209 Personality disorders and disturbances in behaviour 10034726 Psychiatric disorders 10037175 Not Serious 0 18-Apr-2017 18-Apr-2017 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9675018 01108 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 Anxiety Anxiety Anxiety 10002855 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 18-Apr-2017 18-Apr-2017 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9675018 01108 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 throat irritation Throat irritation Throat irritation 10043521 Throat irritation 10043521 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 24-Apr-2017 24-Apr-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9675018 01108 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 7 Exacerbation of paranoia Paranoia aggravated Paranoia aggravated 10033865 Paranoia 10033864 Behaviour and socialisation disturbances 10004209 Personality disorders and disturbances in behaviour 10034726 Psychiatric disorders 10037175 Not Serious 0 21-Apr-2017 21-Apr-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 9675018 01108 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 8 8 exacerbation of paranoia Paranoia aggravated Paranoia aggravated 10033865 Paranoia 10033864 Behaviour and socialisation disturbances 10004209 Personality disorders and disturbances in behaviour 10034726 Psychiatric disorders 10037175 Not Serious 0 10-Jun-2017 12-Jun-2017 Moderate 2 Continuous 2 Other (specify) 8 study drug Full Recovery/Return to Baseline 1 Possibly Related 1 9675018 01108 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 9 9 irritability Irritability Irritability 10022998 Irritability 10022998 Emotional and mood disturbances NEC 10014556 Mood disorders and disturbances NEC 10027946 Psychiatric disorders 10037175 Not Serious 0 20-Jul-2017 20-Jul-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 9675018 01108 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 10 10 exacerbation of paranoia Paranoia aggravated Paranoia aggravated 10033865 Paranoia 10033864 Behaviour and socialisation disturbances 10004209 Personality disorders and disturbances in behaviour 10034726 Psychiatric disorders 10037175 Not Serious 0 21-Jul-2017 25-Jul-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 9675018 01109 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 9854159 01109 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 Fatigue Fatigue Fatigue 10016256 Fatigue 10016256 Asthenic conditions 10003550 General system disorders NEC 10018073 General disorders and administration site conditions 10018065 Not Serious 0 27-May-2017 06-Jun-2017 Moderate 2 Single/Intermittent 1 Other (specify) 8 'slept a lot' Full Recovery/Return to Baseline 1 Possibly Related 1 9854159 01109 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 shortness of breath Shortness of breath Shortness of breath 10040604 Dyspnoea 10013968 Breathing abnormalities 10006334 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 09-Jun-2017 09-Jun-2017 Mild 1 Single/Intermittent 1 Prescription Medication 4 Full Recovery/Return to Baseline 1 Probably Related 2 9854159 01112 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 9710818 01112 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 upper respiratory infection Upper respiratory infection Upper respiratory infection 10046300 Upper respiratory tract infection 10046306 Upper respiratory tract infections 10046309 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 15-May-2017 17-May-2017 Mild 1 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 9710818 01112 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 Tachycardia Tachycardia Tachycardia 10043071 Tachycardia 10043071 Rate and rhythm disorders NEC 10037908 Cardiac arrhythmias 10007521 Cardiac disorders 10007541 Not Serious 0 16-May-2017 16-May-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9710818 01112 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 Agitation Agitation Agitation 10001497 Agitation 10001497 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 16-May-2017 16-May-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9710818 01112 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 Food poisoning Food poisoning Food poisoning 10016952 Food poisoning 10016952 Gastrointestinal disorders NEC 10017948 Gastrointestinal conditions NEC 10017943 Gastrointestinal disorders 10017947 Not Serious 0 31-May-2017 01-Jun-2017 Moderate 2 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 9710818 01112 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 Exacerbation of Back pain Back pain aggravated Back pain aggravated 10048412 Back pain 10003988 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 18-Jun-2017 22-Jun-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 9710818 01112 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 Throat irritation Throat irritation Throat irritation 10043521 Throat irritation 10043521 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 08-Jun-2017 28-Jun-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9710818 01110 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 9710661 01110 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 Headache Headache Headache 10019211 Headache 10019211 Headaches NEC 10019233 Headaches 10019231 Nervous system disorders 10029205 Not Serious 0 29-Apr-2017 30-Apr-2017 Severe 3 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 9710661 01110 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 upper respiratory infection Upper respiratory infection Upper respiratory infection 10046300 Upper respiratory tract infection 10046306 Upper respiratory tract infections 10046309 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 02-May-2017 04-May-2017 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 9710661 01110 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 exacerbation of insomnia Insomnia exacerbated Insomnia exacerbated 10022440 Insomnia 10022437 Disturbances in initiating and maintaining sleep 10013510 Sleep disorders and disturbances 10040991 Psychiatric disorders 10037175 Not Serious 0 11-May-2017 08-Jul-2017 Moderate 2 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Possibly Related 1 9710661 01110 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 Depression Depression Depression 10012378 Depression 10012378 Depressive disorders 10012401 Depressed mood disorders and disturbances 10012375 Psychiatric disorders 10037175 Not Serious 0 12-Jun-2017 15-Aug-2017 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 9710661 01110 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 constricted breathing Difficulty breathing Difficulty breathing 10012791 Dyspnoea 10013968 Breathing abnormalities 10006334 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 03-Jul-2017 12-Jul-2017 Moderate 2 Continuous 2 Prescription Medication,Other (specify) 4,8 seen in ER Full Recovery/Return to Baseline 1 Not Related 0 9710661 01110 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 exacerbation of anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 03-Jul-2017 12-Jul-2017 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 9710661 01111 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) Yes 1 9854892 01113 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 9650706 01113 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 Difficulty concentrating Concentration impaired Concentration impaired 10010249 Disturbance in attention 10013496 Mental impairment (excl dementia and memory loss) 10027375 Mental impairment disorders 10057167 Nervous system disorders 10029205 Not Serious 0 19-May-2017 19-May-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9650706 01113 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 Exacerbation of insomnia Insomnia exacerbated Insomnia exacerbated 10022440 Insomnia 10022437 Disturbances in initiating and maintaining sleep 10013510 Sleep disorders and disturbances 10040991 Psychiatric disorders 10037175 Not Serious 0 25-May-2017 31-May-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9650706 01113 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 Difficulty concentrating Concentration impaired Concentration impaired 10010249 Disturbance in attention 10013496 Mental impairment (excl dementia and memory loss) 10027375 Mental impairment disorders 10057167 Nervous system disorders 10029205 Not Serious 0 16-May-2017 16-May-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9650706 01113 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 Difficulty Concentrating Concentration impaired Concentration impaired 10010249 Disturbance in attention 10013496 Mental impairment (excl dementia and memory loss) 10027375 Mental impairment disorders 10057167 Nervous system disorders 10029205 Not Serious 0 10-May-2017 10-May-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9650706 01113 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 Difficulty concentrating Concentration impaired Concentration impaired 10010249 Disturbance in attention 10013496 Mental impairment (excl dementia and memory loss) 10027375 Mental impairment disorders 10057167 Nervous system disorders 10029205 Not Serious 0 02-May-2017 03-May-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9650706 01113 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 Difficulty concentrating Concentration impaired Concentration impaired 10010249 Disturbance in attention 10013496 Mental impairment (excl dementia and memory loss) 10027375 Mental impairment disorders 10057167 Nervous system disorders 10029205 Not Serious 0 07-May-2017 07-May-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9650706 01113 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 7 Exacerbation of anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 31-May-2017 01-Jun-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9650706 01113 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 8 8 Irritability Irritability Irritability 10022998 Irritability 10022998 Emotional and mood disturbances NEC 10014556 Mood disorders and disturbances NEC 10027946 Psychiatric disorders 10037175 Not Serious 0 24-May-2017 20-Jul-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 9650706 01113 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 9 9 Fatigue Fatigue Fatigue 10016256 Fatigue 10016256 Asthenic conditions 10003550 General system disorders NEC 10018073 General disorders and administration site conditions 10018065 Not Serious 0 10-Jun-2017 16-Jun-2017 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 9650706 01113 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 10 10 Stomach discomfort Stomach discomfort Stomach discomfort 10042101 Abdominal discomfort 10000059 Gastrointestinal signs and symptoms NEC 10027678 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 13-Jun-2017 13-Jun-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 9650706 01113 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 11 11 Bronchitis Bronchitis Bronchitis 10006451 Bronchitis 10006451 Lower respiratory tract and lung infections 10025101 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 10-Jul-2017 14-Jul-2017 Moderate 2 Single/Intermittent 1 Prescription Medication 4 Full Recovery/Return to Baseline 1 Not Related 0 9650706 01113 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 12 12 Confusion Confusion Confusion 10010300 Confusional state 10010305 Confusion and disorientation 10010301 Deliria (incl confusion) 10012221 Psychiatric disorders 10037175 Not Serious 0 28-Jun-2017 30-Jun-2017 Moderate 2 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Possibly Related 1 9650706 01113 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 14 13 Exacerbation of Fatigue Fatigue aggravated Fatigue aggravated 10048415 Fatigue 10016256 Asthenic conditions 10003550 General system disorders NEC 10018073 General disorders and administration site conditions 10018065 Not Serious 0 14-Jul-2017 23-Nov-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 9650706 01113 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 16 14 irritability Irritability Irritability 10022998 Irritability 10022998 Emotional and mood disturbances NEC 10014556 Mood disorders and disturbances NEC 10027946 Psychiatric disorders 10037175 Not Serious 0 05-Jul-2017 21-Jul-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 9650706 01114 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 9771831 01114 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 light-headedness Lightheadedness Lightheadedness 10024492 Dizziness 10013573 Neurological signs and symptoms NEC 10029306 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 04-May-2017 04-May-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9771831 01114 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 vomiting Vomiting Vomiting 10047700 Vomiting 10047700 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 18-May-2017 18-May-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 9771831 01114 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 vomiting Vomiting Vomiting 10047700 Vomiting 10047700 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 26-May-2017 26-May-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 9771831 01114 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 paranoia Paranoia Paranoia 10033864 Paranoia 10033864 Behaviour and socialisation disturbances 10004209 Personality disorders and disturbances in behaviour 10034726 Psychiatric disorders 10037175 Not Serious 0 13-Jun-2017 13-Jun-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9771831 01114 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 paranoia Paranoia Paranoia 10033864 Paranoia 10033864 Behaviour and socialisation disturbances 10004209 Personality disorders and disturbances in behaviour 10034726 Psychiatric disorders 10037175 Not Serious 0 17-Jun-2017 20-Jun-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9771831 01114 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 Nausea Nausea Nausea 10028813 Nausea 10028813 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 17-Jun-2017 20-Jun-2017 Moderate 2 Continuous 2 Other (specify) 8 decreased food intake Full Recovery/Return to Baseline 1 Probably Related 2 9771831 01114 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 7 exacerbation of anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 17-Jun-2017 20-Jun-2017 Moderate 2 Single/Intermittent 1 Other (specify) 8 decreased study drug dose Full Recovery/Return to Baseline 1 Probably Related 2 9771831 01114 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 8 8 Throat irritation Throat irritation Throat irritation 10043521 Throat irritation 10043521 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 25-Jun-2017 05-Jul-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9771831 01114 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 11 9 Stomach virus Stomach virus Stomach virus 10042125 Gastroenteritis viral 10017918 Viral infections NEC 10047465 Viral infectious disorders 10047438 Infections and infestations 10021881 Not Serious 0 14-Jul-2017 17-Jul-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 9771831 01114 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 12 10 insect bites Insect bite NOS Insect bite NOS 10022403 Arthropod bite 10003399 Non-site specific injuries NEC 10029511 Injuries NEC 10022114 Injury, poisoning and procedural complications 10022117 Not Serious 0 01-Jun-2017 01-Jul-2017 Mild 1 Single/Intermittent 1 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 9771831 01115 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 9968779 01115 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 Throat irritation Throat irritation Throat irritation 10043521 Throat irritation 10043521 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 24-May-2017 08-Jun-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9968779 01116 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) Yes 1 9968790 01117 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 9866626 01117 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 Exacerbation of back pain Back pain aggravated Back pain aggravated 10048412 Back pain 10003988 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 30-May-2017 01-Aug-2017 Moderate 2 Continuous 2 Prescription Medication,Other (specify) 4,8 study drug Full Recovery/Return to Baseline 1 Not Related 0 9866626 01117 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 irritability Irritability Irritability 10022998 Irritability 10022998 Emotional and mood disturbances NEC 10014556 Mood disorders and disturbances NEC 10027946 Psychiatric disorders 10037175 Not Serious 0 01-Aug-2017 Mild 1 Continuous 2 None 0 Persists, Diminishing 2 Possibly Related 1 9866626 01117 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 increased libido Increased libido Increased libido 10021669 Libido increased 10024421 Sexual desire disorders 10040470 Sexual dysfunctions, disturbances and gender identity disorders 10040480 Psychiatric disorders 10037175 Not Serious 0 31-May-2017 25-Aug-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9866626 01118 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 9786869 01118 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 Headache Headache Headache 10019211 Headache 10019211 Headaches NEC 10019233 Headaches 10019231 Nervous system disorders 10029205 Not Serious 0 01-Jun-2017 01-Jun-2017 Mild 1 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Possibly Related 1 9786869 01118 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 cough Cough Cough 10011224 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 12-Jul-2017 15-Jul-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9786869 01119 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 9866888 01119 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 Exacerbation of Memory impairment Memory impairment Memory impairment 10027175 Memory impairment 10027175 Memory loss (excl dementia) 10027177 Mental impairment disorders 10057167 Nervous system disorders 10029205 Not Serious 0 26-Jun-2017 11-Jul-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9866888 01119 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 2 Respiratory infection Respiratory infection Respiratory infection 10038700 Respiratory tract infection 10062352 Infections NEC 10021902 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 09-Jul-2017 19-Jul-2017 Moderate 2 Continuous 2 Prescription Medication 4 Full Recovery/Return to Baseline 1 Possibly Related 1 9866888 01119 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 3 Contusions Contusion Contusion 10050584 Contusion 10050584 Skin injuries NEC 10027699 Injuries NEC 10022114 Injury, poisoning and procedural complications 10022117 Not Serious 0 07-Jul-2017 31-Jul-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 9866888 01119 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 4 Throat irritation Throat irritation Throat irritation 10043521 Throat irritation 10043521 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 01-Jul-2017 19-Jul-2017 Moderate 2 Single/Intermittent 1 Withdrawn from Study Due to Adverse Event 3 Full Recovery/Return to Baseline 1 Probably Related 2 9866888 01119 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 5 Exacerbation of back pain Back pain aggravated Back pain aggravated 10048412 Back pain 10003988 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 07-Jul-2017 UN-Sep-2017 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 9866888 01119 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 6 Fall Fall Fall 10016173 Fall 10016173 Non-site specific injuries NEC 10029511 Injuries NEC 10022114 Injury, poisoning and procedural complications 10022117 Not Serious 0 07-Jul-2017 07-Jul-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9866888 01120 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 9866889 01120 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 Exacerbation of Depression Depression aggravated Depression aggravated 10012379 Depression 10012378 Depressive disorders 10012401 Depressed mood disorders and disturbances 10012375 Psychiatric disorders 10037175 Not Serious 0 12-Jul-2017 15-Jul-2017 Moderate 2 Single/Intermittent 1 Withdrawn from Study Due to Adverse Event 3 Full Recovery/Return to Baseline 1 Probably Related 2 9866889 01121 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 9953178 01121 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 paranoia Paranoia Paranoia 10033864 Paranoia 10033864 Behaviour and socialisation disturbances 10004209 Personality disorders and disturbances in behaviour 10034726 Psychiatric disorders 10037175 Not Serious 0 07-Aug-2017 07-Aug-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9953178 01121 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 cough Cough Cough 10011224 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 08-Aug-2017 29-Aug-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 9953178 01121 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 Heart palpitations Palpitations Palpitations 10033557 Palpitations 10033557 Cardiac signs and symptoms NEC 10007609 Cardiac disorder signs and symptoms 10007539 Cardiac disorders 10007541 Not Serious 0 12-Sep-2017 Mild 1 Single/Intermittent 1 None 0 Persists, Worsening 4 Not Related 0 9953178 01121 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 heart palpitations Palpitations Palpitations 10033557 Palpitations 10033557 Cardiac signs and symptoms NEC 10007609 Cardiac disorder signs and symptoms 10007539 Cardiac disorders 10007541 Serious 1 16-Sep-2017 Moderate 2 Single/Intermittent 1 Withdrawn from Study Due to Adverse Event,Hospitalization 3,6 Persists, Diminishing 2 Not Related 0 9953178 01121 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 Heart palpitations Palpitations Palpitations 10033557 Palpitations 10033557 Cardiac signs and symptoms NEC 10007609 Cardiac disorder signs and symptoms 10007539 Cardiac disorders 10007541 Not Serious 0 18-Sep-2017 Mild 1 Single/Intermittent 1 None 0 Persists, the Same 3 Not Related 0 9953178 01121 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 increased awareness of somatic symptoms Abnormal physical sensation Abnormal physical sensation 10000163 Sensory disturbance 10040026 Sensory abnormalities NEC 10040021 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 14-Aug-2017 14-Aug-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 9953178 01122 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 10064375 01122 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 increased headache frequency Frequent headaches Frequent headaches 10052403 Headache 10019211 Headaches NEC 10019233 Headaches 10019231 Nervous system disorders 10029205 Not Serious 0 15-Sep-2017 22-Sep-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 10064375 01122 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 Upper respiratory infection Upper respiratory infection Upper respiratory infection 10046300 Upper respiratory tract infection 10046306 Upper respiratory tract infections 10046309 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 22-Sep-2017 25-Sep-2017 Moderate 2 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 10064375 01122 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 Irritability Irritability Irritability 10022998 Irritability 10022998 Emotional and mood disturbances NEC 10014556 Mood disorders and disturbances NEC 10027946 Psychiatric disorders 10037175 Not Serious 0 09-Oct-2017 19-Oct-2017 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 10064375 01123 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 10004056 01123 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 Throat irritation Throat irritation Throat irritation 10043521 Throat irritation 10043521 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 11-Aug-2017 31-Aug-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 10004056 01123 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 upper respiratory congestion Upper respiratory tract congestion Upper respiratory tract congestion 10052252 Upper respiratory tract congestion 10052252 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 11-Aug-2017 31-Aug-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 10004056 01123 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 cough Cough Cough 10011224 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 11-Aug-2017 31-Aug-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 10004056 01123 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 skin irritation Skin irritation Skin irritation 10040880 Skin irritation 10040880 Dermatitis and eczema 10012435 Epidermal and dermal conditions 10014982 Skin and subcutaneous tissue disorders 10040785 Not Serious 0 17-Aug-2017 20-Aug-2017 Mild 1 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 10004056 01123 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 upper respiratory congestion Upper respiratory tract congestion Upper respiratory tract congestion 10052252 Upper respiratory tract congestion 10052252 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 04-Sep-2017 17-Sep-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 10004056 01123 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 Throat irritation Throat irritation Throat irritation 10043521 Throat irritation 10043521 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 12-Sep-2017 04-Oct-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 10004056 01123 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 7 Cough Cough Cough 10011224 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 12-Sep-2017 04-Oct-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 10004056 01123 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 8 8 irritability Irritability Irritability 10022998 Irritability 10022998 Emotional and mood disturbances NEC 10014556 Mood disorders and disturbances NEC 10027946 Psychiatric disorders 10037175 Not Serious 0 10-Aug-2017 10-Aug-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 10004056 01123 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 9 9 recurrence of panic attack Panic attack Panic attack 10033664 Panic attack 10033664 Panic attacks and disorders 10068300 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 26-Sep-2017 27-Sep-2017 Moderate 2 Single/Intermittent 1 Other (specify) 8 study IP Full Recovery/Return to Baseline 1 Not Related 0 10004056 01123 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 10 10 Exacerbation of back pain Back pain aggravated Back pain aggravated 10048412 Back pain 10003988 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 13-Oct-2017 06-Nov-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 10004056 01124 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 10002100 01124 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 sleepiness Sleepiness Sleepiness 10041014 Somnolence 10041349 Disturbances in consciousness NEC 10013509 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 15-Aug-2017 16-Aug-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 10002100 01125 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 10039090 01125 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 sinus congestion Sinus congestion Sinus congestion 10040742 Sinus congestion 10040742 Paranasal sinus disorders (excl infections and neoplasms) 10040743 Upper respiratory tract disorders (excl infections) 10046304 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 02-Sep-2017 31-Oct-2017 Mild 1 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 10039090 01125 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 throat irritation Throat irritation Throat irritation 10043521 Throat irritation 10043521 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 29-Aug-2017 21-Sep-2017 Moderate 2 Single/Intermittent 1 Prescription Medication,Non-prescription Medication 4,5 Full Recovery/Return to Baseline 1 Probably Related 2 10039090 01125 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 cough Cough Cough 10011224 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 29-Aug-2017 21-Sep-2017 Mild 1 Single/Intermittent 1 Prescription Medication,Non-prescription Medication 4,5 Full Recovery/Return to Baseline 1 Probably Related 2 10039090 01125 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 4 diarrhea Diarrhea Diarrhea 10012727 Diarrhoea 10012735 Diarrhoea (excl infective) 10012736 Gastrointestinal motility and defaecation conditions 10017977 Gastrointestinal disorders 10017947 Not Serious 0 16-Sep-2017 17-Sep-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 10039090 01125 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 5 nausea Nausea Nausea 10028813 Nausea 10028813 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 16-Sep-2017 17-Sep-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 10039090 01125 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 6 irritability Irritability Irritability 10022998 Irritability 10022998 Emotional and mood disturbances NEC 10014556 Mood disorders and disturbances NEC 10027946 Psychiatric disorders 10037175 Not Serious 0 12-Sep-2017 12-Sep-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 10039090 01125 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 8 7 irritability Irritability Irritability 10022998 Irritability 10022998 Emotional and mood disturbances NEC 10014556 Mood disorders and disturbances NEC 10027946 Psychiatric disorders 10037175 Not Serious 0 22-Sep-2017 17-Oct-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 10039090 01125 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 9 8 exacerbation of anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 22-Sep-2017 17-Oct-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 10039090 01125 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 10 9 peripheral neuropathy Peripheral neuropathy NOS Peripheral neuropathy NOS 10034610 Neuropathy peripheral 10029331 Peripheral neuropathies NEC 10034607 Peripheral neuropathies 10034606 Nervous system disorders 10029205 Not Serious 0 15-Nov-2017 Moderate 2 Single/Intermittent 1 Procedure or Therapy 1 Persists, the Same 3 Not Related 0 10039090 01126 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 10021383 01126 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 diarrhea Diarrhea Diarrhea 10012727 Diarrhoea 10012735 Diarrhoea (excl infective) 10012736 Gastrointestinal motility and defaecation conditions 10017977 Gastrointestinal disorders 10017947 Not Serious 0 08-Sep-2017 10-Sep-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 10021383 01126 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 Exacerbation of arthritis Arthritis aggravated Arthritis aggravated 10003247 Arthritis 10003246 Arthropathies NEC 10003284 Joint disorders 10023213 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 15-Sep-2017 04-Apr-2018 Severe 3 Continuous 2 Prescription Medication 4 Full Recovery/Return to Baseline 1 Not Related 0 10021383 01126 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 Pulmonary embolism Pulmonary embolism Pulmonary embolism 10037377 Pulmonary embolism 10037377 Pulmonary thrombotic and embolic conditions 10037439 Pulmonary vascular disorders 10037454 Respiratory, thoracic and mediastinal disorders 10038738 Serious 1 17-Oct-2017 25-Oct-2017 Severe 3 Continuous 2 Withdrawn from Study Due to Adverse Event,Prescription Medication,Hospitalization 3,4,6 Full Recovery/Return to Baseline 1 Not Related 0 10021383 01126 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 Pulmonary embolism Pulmonary embolism Pulmonary embolism 10037377 Pulmonary embolism 10037377 Pulmonary thrombotic and embolic conditions 10037439 Pulmonary vascular disorders 10037454 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 26-Oct-2017 30-Jan-2018 Mild 1 Continuous 2 Prescription Medication 4 Full Recovery/Return to Baseline 1 Not Related 0 10021383 01127 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) Yes 1 11362544 01128 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11362551 01128 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 1 cough Cough Cough 10011224 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 11-Oct-2017 18-Oct-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11362551 01128 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 2 Exacerbation of anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 11-Oct-2017 23-Oct-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 11362551 01128 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 3 cough Cough Cough 10011224 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 19-Nov-2017 26-Nov-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11362551 01129 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 10125962 01129 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 nausea Nausea Nausea 10028813 Nausea 10028813 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 24-Oct-2017 24-Oct-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 10125962 01129 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 nausea Nausea Nausea 10028813 Nausea 10028813 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 02-Nov-2017 02-Nov-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 10125962 01129 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 upper respiratory infection Upper respiratory infection Upper respiratory infection 10046300 Upper respiratory tract infection 10046306 Upper respiratory tract infections 10046309 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 10-Nov-2017 14-Nov-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 10125962 01129 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 headache Headache Headache 10019211 Headache 10019211 Headaches NEC 10019233 Headaches 10019231 Nervous system disorders 10029205 Not Serious 0 10-Nov-2017 14-Nov-2017 Moderate 2 Continuous 2 Other (specify) 8 icepack Full Recovery/Return to Baseline 1 Not Related 0 10125962 01129 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 Nausea Nausea Nausea 10028813 Nausea 10028813 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 09-Nov-2017 09-Nov-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 10125962 01129 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 streptococcus infection Streptococcal infection Streptococcal infection 10061372 Streptococcal infection 10061372 Streptococcal infections 10042180 Bacterial infectious disorders 10004018 Infections and infestations 10021881 Not Serious 0 14-Jan-2018 20-Jan-2018 Severe 3 Continuous 2 Prescription Medication 4 Full Recovery/Return to Baseline 1 Not Related 0 10125962 01129 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 7 dislocated shoulder Dislocated shoulder Dislocated shoulder 10013156 Joint dislocation 10023204 Fractures and dislocations NEC 10027677 Bone and joint injuries 10005942 Injury, poisoning and procedural complications 10022117 Not Serious 0 26-Dec-2017 28-Dec-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 10125962 01129 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 8 8 dislocated shoulder Dislocated shoulder Dislocated shoulder 10013156 Joint dislocation 10023204 Fractures and dislocations NEC 10027677 Bone and joint injuries 10005942 Injury, poisoning and procedural complications 10022117 Not Serious 0 13-Jan-2018 13-Jan-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 10125962 01129 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 9 9 nasal congestion Nasal congestion Nasal congestion 10028735 Nasal congestion 10028735 Nasal congestion and inflammations 10028736 Upper respiratory tract disorders (excl infections) 10046304 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 30-Jan-2018 22-Feb-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 10125962 01129 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 10 10 shoulder injury Injury to shoulder NOS Injury to shoulder NOS 10022336 Joint injury 10060820 Bone and joint injuries NEC 10074485 Bone and joint injuries 10005942 Injury, poisoning and procedural complications 10022117 Not Serious 0 04-Mar-2018 Severe 3 Continuous 2 Other (specify) 8 ER visit Persists, the Same 3 Not Related 0 10125962 01129 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 11 11 upper respiratory infection Upper respiratory infection Upper respiratory infection 10046300 Upper respiratory tract infection 10046306 Upper respiratory tract infections 10046309 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 10-Mar-2018 30-Mar-2018 Mild 1 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 10125962 01129 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 12 12 exacerbation of hypothyroidism Hypothyroidism Hypothyroidism 10021114 Hypothyroidism 10021114 Thyroid hypofunction disorders 10043741 Thyroid gland disorders 10043739 Endocrine disorders 10014698 Not Serious 0 24-Apr-2018 Moderate 2 Continuous 2 Other (specify) 8 increased dosage of thyroid meds Persists, the Same 3 Not Related 0 10125962 01129 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 13 13 upper respiratory infection Upper respiratory infection Upper respiratory infection 10046300 Upper respiratory tract infection 10046306 Upper respiratory tract infections 10046309 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 25-Dec-2017 28-Dec-2017 Moderate 2 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 10125962 01130 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) Yes 1 11376028 01131 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11363754 01131 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 dry mouth Dry mouth Dry mouth 10013781 Dry mouth 10013781 Oral dryness and saliva altered 10030975 Salivary gland conditions 10039404 Gastrointestinal disorders 10017947 Not Serious 0 01-Nov-2017 27-Nov-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11363754 01131 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 irritability Irritability Irritability 10022998 Irritability 10022998 Emotional and mood disturbances NEC 10014556 Mood disorders and disturbances NEC 10027946 Psychiatric disorders 10037175 Not Serious 0 29-Nov-2017 11-Dec-2017 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 11363754 01131 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 emotional lability Emotional lability Emotional lability 10014555 Affect lability 10054196 Affect alterations NEC 10001438 Mood disorders and disturbances NEC 10027946 Psychiatric disorders 10037175 Not Serious 0 29-Nov-2017 11-Dec-2017 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 11363754 01131 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 anger Anger Anger 10002368 Anger 10002368 Emotional and mood disturbances NEC 10014556 Mood disorders and disturbances NEC 10027946 Psychiatric disorders 10037175 Not Serious 0 29-Nov-2017 11-Dec-2017 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 11363754 01131 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 Exacerbation of anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 01-Dec-2017 11-Dec-2017 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 11363754 01131 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 paranoia Paranoia Paranoia 10033864 Paranoia 10033864 Behaviour and socialisation disturbances 10004209 Personality disorders and disturbances in behaviour 10034726 Psychiatric disorders 10037175 Not Serious 0 02-Dec-2017 11-Dec-2017 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 11363754 01131 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 7 dry eyes Dry eyes Dry eyes 10013778 Dry eye 10013774 Lacrimation disorders 10072989 Eye disorders NEC 10015917 Eye disorders 10015919 Not Serious 0 01-Nov-2017 27-Nov-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11363754 01131 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 8 8 headache Headache Headache 10019211 Headache 10019211 Headaches NEC 10019233 Headaches 10019231 Nervous system disorders 10029205 Not Serious 0 12-Dec-2017 03-Jan-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11363754 01131 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 9 9 exacerbation of migraines Migraine aggravated Migraine aggravated 10027600 Migraine 10027599 Migraine headaches 10027603 Headaches 10019231 Nervous system disorders 10029205 Not Serious 0 13-Dec-2017 23-Dec-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11363754 01131 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 10 10 nausea Nausea Nausea 10028813 Nausea 10028813 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 27-Dec-2017 11-Jan-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 11363754 01131 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 11 11 emesis Emesis Emesis 10014542 Vomiting 10047700 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 30-Dec-2017 30-Dec-2017 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 11363754 01131 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 12 12 increased sensitivity to smells Altered smell sensation Altered smell sensation 10001853 Parosmia 10034018 Olfactory nerve disorders 10030281 Cranial nerve disorders (excl neoplasms) 10011305 Nervous system disorders 10029205 Not Serious 0 27-Dec-2017 11-Jan-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11363754 01131 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 13 13 pressure at temples Sensation of pressure NOS Sensation of pressure NOS 10040005 Discomfort 10013082 Pain and discomfort NEC 10033372 General system disorders NEC 10018073 General disorders and administration site conditions 10018065 Not Serious 0 12-Dec-2017 11-Jan-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 11363754 01131 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 14 14 dizziness Dizziness Dizziness 10013573 Dizziness 10013573 Neurological signs and symptoms NEC 10029306 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 30-Dec-2017 11-Jan-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11363754 01131 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 15 15 lethargy Lethargy Lethargy 10024264 Lethargy 10024264 Disturbances in consciousness NEC 10013509 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 09-Jan-2018 24-Jan-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11363754 01131 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 16 16 irritability Irritability Irritability 10022998 Irritability 10022998 Emotional and mood disturbances NEC 10014556 Mood disorders and disturbances NEC 10027946 Psychiatric disorders 10037175 Not Serious 0 09-Jan-2018 24-Jan-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11363754 01131 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 17 17 irritability Irritability Irritability 10022998 Irritability 10022998 Emotional and mood disturbances NEC 10014556 Mood disorders and disturbances NEC 10027946 Psychiatric disorders 10037175 Not Serious 0 06-Nov-2017 17-Nov-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 11363754 01132 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 10086107 01132 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 sinus congestion Sinus congestion Sinus congestion 10040742 Sinus congestion 10040742 Paranasal sinus disorders (excl infections and neoplasms) 10040743 Upper respiratory tract disorders (excl infections) 10046304 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 14-Nov-2017 17-Nov-2017 Mild 1 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Possibly Related 1 10086107 01132 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 headache Headache Headache 10019211 Headache 10019211 Headaches NEC 10019233 Headaches 10019231 Nervous system disorders 10029205 Not Serious 0 17-Nov-2017 17-Nov-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 10086107 01132 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 throat irritation Throat irritation Throat irritation 10043521 Throat irritation 10043521 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 14-Nov-2017 07-Dec-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 10086107 01132 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 cough Cough Cough 10011224 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 14-Nov-2017 07-Dec-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 10086107 01132 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 disrupted equilibrium Equilibrium disorder of (NOS) Equilibrium disorder of (NOS) 10015111 Balance disorder 10049848 Coordination and balance disturbances 10072984 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 02-Dec-2017 02-Dec-2017 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 10086107 01132 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 anger Anger Anger 10002368 Anger 10002368 Emotional and mood disturbances NEC 10014556 Mood disorders and disturbances NEC 10027946 Psychiatric disorders 10037175 Not Serious 0 08-Dec-2017 14-Jan-2018 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 10086107 01132 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 7 increased intrusive thoughts Obsessive thoughts Obsessive thoughts 10029897 Obsessive thoughts 10029897 Obsessive-compulsive disorders and symptoms 10068758 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 23-Dec-2017 14-Jan-2018 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 10086107 01132 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 8 8 general malaise General malaise General malaise 10018066 Malaise 10025482 Asthenic conditions 10003550 General system disorders NEC 10018073 General disorders and administration site conditions 10018065 Not Serious 0 28-Dec-2017 02-Jan-2018 Severe 3 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 10086107 01132 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 9 9 diarrhea Diarrhea Diarrhea 10012727 Diarrhoea 10012735 Diarrhoea (excl infective) 10012736 Gastrointestinal motility and defaecation conditions 10017977 Gastrointestinal disorders 10017947 Not Serious 0 27-Dec-2017 28-Dec-2017 Moderate 2 Single/Intermittent 1 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 10086107 01132 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 10 10 diarrhea Diarrhea Diarrhea 10012727 Diarrhoea 10012735 Diarrhoea (excl infective) 10012736 Gastrointestinal motility and defaecation conditions 10017977 Gastrointestinal disorders 10017947 Not Serious 0 10-Jan-2018 13-Jan-2018 Moderate 2 Single/Intermittent 1 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 10086107 01132 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 11 11 cough Cough Cough 10011224 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 12-Jan-2018 12-Jan-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 10086107 01132 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 12 12 exacerbation of tinnitus Tinnitus aggravated Tinnitus aggravated 10043883 Tinnitus 10043882 Inner ear signs and symptoms 10022398 Inner ear and VIIIth cranial nerve disorders 10022396 Ear and labyrinth disorders 10013993 Not Serious 0 22-Feb-2018 Mild 1 Single/Intermittent 1 None 0 Persists, the Same 3 Not Related 0 10086107 01132 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 13 13 sore throat Sore throat Sore throat 10041367 Oropharyngeal pain 10068319 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 26-Feb-2018 27-Feb-2018 Mild 1 Single/Intermittent 1 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 10086107 01132 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 14 14 cloudy urine Cloudy urine Cloudy urine 10009686 Urine abnormality 10046607 Urinary abnormalities 10000196 Urinary tract signs and symptoms 10046590 Renal and urinary disorders 10038359 Not Serious 0 17-Nov-2017 17-Nov-2017 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 10086107 01132 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 15 15 sore throat Sore throat Sore throat 10041367 Oropharyngeal pain 10068319 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 08-Dec-2017 09-Dec-2017 Mild 1 Single/Intermittent 1 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 10086107 01132 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 16 16 emotional disturbance Emotional disturbance NOS Emotional disturbance NOS 10014553 Emotional disorder 10014551 Emotional and mood disturbances NEC 10014556 Mood disorders and disturbances NEC 10027946 Psychiatric disorders 10037175 Not Serious 0 18-Jan-2018 18-Jan-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 10086107 01133 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11369190 01133 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 Cough Cough Cough 10011224 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 14-Dec-2017 04-Jan-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11369190 01133 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 muscle soreness Muscle soreness Muscle soreness 10028332 Myalgia 10028411 Muscle pains 10028323 Muscle disorders 10028302 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 25-Dec-2017 01-Jan-2018 Mild 1 Single/Intermittent 1 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 11369190 01133 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 acute torticollis Acute torticollis Acute torticollis 10066657 Torticollis 10044074 Muscle tone abnormalities 10028343 Muscle disorders 10028302 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 01-Jan-2018 10-Jan-2018 Moderate 2 Single/Intermittent 1 Prescription Medication 4 Full Recovery/Return to Baseline 1 Not Related 0 11369190 01133 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 exacerbation of depression Depression aggravated Depression aggravated 10012379 Depression 10012378 Depressive disorders 10012401 Depressed mood disorders and disturbances 10012375 Psychiatric disorders 10037175 Not Serious 0 08-Jan-2018 13-Jan-2018 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11369190 01133 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 dry eyes Dry eyes Dry eyes 10013778 Dry eye 10013774 Lacrimation disorders 10072989 Eye disorders NEC 10015917 Eye disorders 10015919 Not Serious 0 16-Jan-2018 09-Feb-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11369190 01133 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 dry mouth Dry mouth Dry mouth 10013781 Dry mouth 10013781 Oral dryness and saliva altered 10030975 Salivary gland conditions 10039404 Gastrointestinal disorders 10017947 Not Serious 0 28-Jan-2018 09-Feb-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11369190 01133 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 7 upper respiratory infection Upper respiratory infection Upper respiratory infection 10046300 Upper respiratory tract infection 10046306 Upper respiratory tract infections 10046309 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 02-Feb-2018 05-Feb-2018 Moderate 2 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 11369190 01133 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 9 8 muscle tension Muscle tension Muscle tension 10070541 Muscle tightness 10049816 Muscle related signs and symptoms NEC 10028326 Muscle disorders 10028302 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 15-Dec-2017 17-Dec-2017 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11369190 01134 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11369211 01134 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 1 recurrence of panic attack Panic attack Panic attack 10033664 Panic attack 10033664 Panic attacks and disorders 10068300 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 10-Jan-2018 10-Jan-2018 Moderate 2 Single/Intermittent 1 Other (specify) 8 study drug Full Recovery/Return to Baseline 1 Not Related 0 11369211 01134 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 2 yeast infection Yeast infection Yeast infection 10049080 Fungal infection 10017533 Fungal infections NEC 10017536 Fungal infectious disorders 10017528 Infections and infestations 10021881 Not Serious 0 18-Jan-2018 06-Feb-2018 Mild 1 Continuous 2 Prescription Medication 4 Full Recovery/Return to Baseline 1 Not Related 0 11369211 01134 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 3 bacterial vaginosis Bacterial vaginosis Bacterial vaginosis 10004055 Bacterial vaginosis 10004055 Bacterial infections NEC 10004047 Bacterial infectious disorders 10004018 Infections and infestations 10021881 Not Serious 0 18-Jan-2018 06-Feb-2018 Mild 1 Continuous 2 Prescription Medication 4 Full Recovery/Return to Baseline 1 Not Related 0 11369211 01135 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11362982 01135 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 nausea Nausea Nausea 10028813 Nausea 10028813 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 02-Jan-2018 02-Jan-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11362982 01135 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 bacterial infection not otherwise specified Bacterial infection NOS Bacterial infection NOS 10004044 Bacterial infection 10060945 Bacterial infections NEC 10004047 Bacterial infectious disorders 10004018 Infections and infestations 10021881 Not Serious 0 02-Mar-2018 09-Mar-2018 Severe 3 Continuous 2 Prescription Medication,Non-prescription Medication 4,5 Full Recovery/Return to Baseline 1 Not Related 0 11362982 01136 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11375312 01136 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 dry mouth Dry mouth Dry mouth 10013781 Dry mouth 10013781 Oral dryness and saliva altered 10030975 Salivary gland conditions 10039404 Gastrointestinal disorders 10017947 Not Serious 0 07-Jan-2018 29-Jan-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11375312 01136 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 influenza Influenza Influenza 10022000 Influenza 10022000 Influenza viral infections 10022005 Viral infectious disorders 10047438 Infections and infestations 10021881 Not Serious 0 09-Jan-2018 15-Jan-2018 Severe 3 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 11375312 01136 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 Exacerbation of anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 11-Feb-2018 21-Feb-2018 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11375312 01136 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 irritability Irritability Irritability 10022998 Irritability 10022998 Emotional and mood disturbances NEC 10014556 Mood disorders and disturbances NEC 10027946 Psychiatric disorders 10037175 Not Serious 0 11-Feb-2018 21-Feb-2018 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11375312 01136 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 dry mouth Dry mouth Dry mouth 10013781 Dry mouth 10013781 Oral dryness and saliva altered 10030975 Salivary gland conditions 10039404 Gastrointestinal disorders 10017947 Not Serious 0 21-Feb-2018 23-Feb-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11375312 01136 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 dry eyes Dry eyes Dry eyes 10013778 Dry eye 10013774 Lacrimation disorders 10072989 Eye disorders NEC 10015917 Eye disorders 10015919 Not Serious 0 21-Feb-2018 23-Feb-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11375312 01136 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 7 diarrhea Diarrhea Diarrhea 10012727 Diarrhoea 10012735 Diarrhoea (excl infective) 10012736 Gastrointestinal motility and defaecation conditions 10017977 Gastrointestinal disorders 10017947 Not Serious 0 25-Feb-2018 26-Feb-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11375312 01136 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 8 8 nausea Nausea Nausea 10028813 Nausea 10028813 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 25-Feb-2018 26-Feb-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11375312 01136 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 9 9 nausea Nausea Nausea 10028813 Nausea 10028813 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 04-Mar-2018 09-Mar-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11375312 01136 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 10 10 vomiting Vomiting NOS Vomiting NOS 10047706 Vomiting 10047700 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 04-Mar-2018 09-Mar-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11375312 01136 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 11 11 diarrhea Diarrhea Diarrhea 10012727 Diarrhoea 10012735 Diarrhoea (excl infective) 10012736 Gastrointestinal motility and defaecation conditions 10017977 Gastrointestinal disorders 10017947 Not Serious 0 04-Mar-2018 09-Mar-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11375312 01136 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 12 12 jaw tension Tightness in jaw Tightness in jaw 10043859 Muscle tightness 10049816 Muscle related signs and symptoms NEC 10028326 Muscle disorders 10028302 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 10-Jan-2018 Mild 1 Single/Intermittent 1 None 0 Persists, Diminishing 2 Possibly Related 1 11375312 01137 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11423436 01137 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 exacerbation of headache Headache aggravated Headache aggravated 10048567 Headache 10019211 Headaches NEC 10019233 Headaches 10019231 Nervous system disorders 10029205 Not Serious 0 14-Jan-2018 14-Jan-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 11423436 01137 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 exacerbation of anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 22-Feb-2018 22-Feb-2018 Severe 3 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11423436 01137 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 nausea Nausea Nausea 10028813 Nausea 10028813 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 22-Feb-2018 22-Feb-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11423436 01137 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 disrupted equilibrium Equilibrium trouble Equilibrium trouble 10050074 Balance disorder 10049848 Coordination and balance disturbances 10072984 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 22-Feb-2018 22-Feb-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11423436 01137 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 intoxication Intoxication Intoxication 10022727 Poisoning 10061355 Poisoning and toxicity 10035777 Exposures, chemical injuries and poisoning 10071947 Injury, poisoning and procedural complications 10022117 Not Serious 0 22-Feb-2018 22-Feb-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11423436 01138 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11440268 01138 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 cough Cough Cough 10011224 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 30-Jan-2018 22-Feb-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11440268 01138 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 dry mouth Dry mouth Dry mouth 10013781 Dry mouth 10013781 Oral dryness and saliva altered 10030975 Salivary gland conditions 10039404 Gastrointestinal disorders 10017947 Not Serious 0 30-Jan-2018 22-Feb-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11440268 01138 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 exacerbation of dry eyes Dry eyes aggravated Dry eyes aggravated 10048422 Dry eye 10013774 Lacrimation disorders 10072989 Eye disorders NEC 10015917 Eye disorders 10015919 Not Serious 0 30-Jan-2018 22-Feb-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11440268 01138 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 sleepiness Sleepiness Sleepiness 10041014 Somnolence 10041349 Disturbances in consciousness NEC 10013509 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 07-Feb-2018 14-Feb-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11440268 01138 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 dry throat Dry throat Dry throat 10013789 Dry throat 10013789 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 11-Mar-2018 31-Mar-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11440268 01138 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 frequent urination Urinary frequency Urinary frequency 10046539 Pollakiuria 10036018 Bladder and urethral symptoms 10004995 Urinary tract signs and symptoms 10046590 Renal and urinary disorders 10038359 Not Serious 0 13-Mar-2018 20-Mar-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 11440268 01138 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 8 upper respiratory infection Upper respiratory infection Upper respiratory infection 10046300 Upper respiratory tract infection 10046306 Upper respiratory tract infections 10046309 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 20-Feb-2018 25-Feb-2018 Mild 1 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 11440268 01138 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 8 7 cough Cough Cough 10011224 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 02-Mar-2018 31-Mar-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11440268 01138 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 9 9 sweating Sweating Sweating 10042661 Hyperhidrosis 10020642 Apocrine and eccrine gland disorders 10002982 Skin appendage conditions 10040798 Skin and subcutaneous tissue disorders 10040785 Not Serious 0 19-Mar-2018 24-Mar-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 11440268 01139 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11436947 01139 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 upper respiratory infection Upper respiratory infection Upper respiratory infection 10046300 Upper respiratory tract infection 10046306 Upper respiratory tract infections 10046309 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 14-Feb-2018 20-Feb-2018 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11436947 01139 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 upper respiratory infection Upper respiratory infection Upper respiratory infection 10046300 Upper respiratory tract infection 10046306 Upper respiratory tract infections 10046309 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 03-Mar-2018 21-Mar-2018 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11436947 01139 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 insomnia Insomnia Insomnia 10022437 Insomnia 10022437 Disturbances in initiating and maintaining sleep 10013510 Sleep disorders and disturbances 10040991 Psychiatric disorders 10037175 Not Serious 0 21-Mar-2018 17-Apr-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 11436947 01139 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 stomach pain Stomach pain Stomach pain 10042112 Abdominal pain upper 10000087 Gastrointestinal and abdominal pains (excl oral and throat) 10017926 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 11-Apr-2018 18-Apr-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11436947 01140 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) Yes 1 100000176870 01141 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11606854 01141 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 Upper respiratory infection Upper respiratory infection Upper respiratory infection 10046300 Upper respiratory tract infection 10046306 Upper respiratory tract infections 10046309 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 17-Feb-2018 21-Feb-2018 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11606854 01141 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 dry mouth Dry mouth Dry mouth 10013781 Dry mouth 10013781 Oral dryness and saliva altered 10030975 Salivary gland conditions 10039404 Gastrointestinal disorders 10017947 Not Serious 0 08-Feb-2018 02-Mar-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11606854 01141 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 dry mouth Dry mouth Dry mouth 10013781 Dry mouth 10013781 Oral dryness and saliva altered 10030975 Salivary gland conditions 10039404 Gastrointestinal disorders 10017947 Not Serious 0 15-Mar-2018 05-Apr-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11606854 01141 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 dry mouth Dry mouth Dry mouth 10013781 Dry mouth 10013781 Oral dryness and saliva altered 10030975 Salivary gland conditions 10039404 Gastrointestinal disorders 10017947 Not Serious 0 18-Apr-2018 27-Apr-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11606854 01142 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11440220 01142 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 suicidal ideation Suicidal ideation Suicidal ideation 10042458 Suicidal ideation 10042458 Suicidal and self-injurious behaviour 10042459 Suicidal and self-injurious behaviours NEC 10042460 Psychiatric disorders 10037175 Not Serious 0 16-Feb-2018 28-Feb-2018 Severe 3 Single/Intermittent 1 Withdrawn from Study Due to Adverse Event 3 Full Recovery/Return to Baseline 1 Possibly Related 1 11440220 01143 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) Yes 1 100000082948 01144 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11504167 01144 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 dizziness Dizziness Dizziness 10013573 Dizziness 10013573 Neurological signs and symptoms NEC 10029306 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 02-Mar-2018 02-Mar-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11504167 01144 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 nausea Nausea Nausea 10028813 Nausea 10028813 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 02-Mar-2018 02-Mar-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11504167 01145 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11627012 01145 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 influenza Influenza Influenza 10022000 Influenza 10022000 Influenza viral infections 10022005 Viral infectious disorders 10047438 Infections and infestations 10021881 Not Serious 0 19-Mar-2018 26-Mar-2018 Severe 3 Continuous 2 IV Fluids 7 Full Recovery/Return to Baseline 1 Not Related 0 11627012 01145 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 pneumonia Pneumonia Pneumonia 10035664 Pneumonia 10035664 Lower respiratory tract and lung infections 10025101 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 23-Mar-2018 27-Apr-2018 Severe 3 Continuous 2 Withdrawn from Study Due to Adverse Event,Prescription Medication 3,4 Full Recovery/Return to Baseline 1 Not Related 0 11627012 01146 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11504184 01146 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 restlessness Restlessness Restlessness 10038743 Restlessness 10038743 Increased physical activity levels 10021672 Changes in physical activity 10008401 Psychiatric disorders 10037175 Not Serious 0 17-Mar-2018 18-Mar-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11504184 01146 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 exacerbation of left arm pain Pain in arm Pain in arm 10033421 Pain in extremity 10033425 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 20-Mar-2018 Moderate 2 Single/Intermittent 1 Prescription Medication 4 Persists, the Same 3 Not Related 0 11504184 01146 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 exacerbation of low back pain Back pain aggravated Back pain aggravated 10048412 Back pain 10003988 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 15-Apr-2018 Moderate 2 Single/Intermittent 1 Prescription Medication 4 Persists, the Same 3 Not Related 0 11504184 01146 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 recurrence of nightmares Nightmares Nightmares 10029414 Nightmare 10029412 Parasomnias 10033920 Sleep disorders and disturbances 10040991 Psychiatric disorders 10037175 Not Serious 0 13-Apr-2018 Moderate 2 Single/Intermittent 1 None 0 Persists, the Same 3 Not Related 0 11504184 01146 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 Exacerbation of insomnia Insomnia exacerbated Insomnia exacerbated 10022440 Insomnia 10022437 Disturbances in initiating and maintaining sleep 10013510 Sleep disorders and disturbances 10040991 Psychiatric disorders 10037175 Not Serious 0 29-Apr-2018 30-Apr-2018 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 11504184 01146 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 exacerbation of anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 03-May-2018 12-May-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11504184 01147 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11481384 01147 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 drowsiness Drowsiness Drowsiness 10013649 Somnolence 10041349 Disturbances in consciousness NEC 10013509 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 13-Mar-2018 20-Mar-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11481384 01147 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 headache Headache Headache 10019211 Headache 10019211 Headaches NEC 10019233 Headaches 10019231 Nervous system disorders 10029205 Not Serious 0 15-Mar-2018 05-Apr-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11481384 01147 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 food poisoning Food poisoning, unspecified Food poisoning, unspecified 10016958 Food poisoning 10016952 Gastrointestinal disorders NEC 10017948 Gastrointestinal conditions NEC 10017943 Gastrointestinal disorders 10017947 Not Serious 0 19-Apr-2018 23-Apr-2018 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11481384 01147 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 muscle soreness Muscle soreness Muscle soreness 10028332 Myalgia 10028411 Muscle pains 10028323 Muscle disorders 10028302 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 10-May-2018 27-May-2018 Mild 1 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 11481384 01147 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 diarrhea Diarrhea Diarrhea 10012727 Diarrhoea 10012735 Diarrhoea (excl infective) 10012736 Gastrointestinal motility and defaecation conditions 10017977 Gastrointestinal disorders 10017947 Not Serious 0 31-May-2018 02-Jun-2018 Moderate 2 Single/Intermittent 1 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 11481384 01147 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 back spasms Muscle spasm Muscle spasm 10028333 Muscle spasms 10028334 Muscle related signs and symptoms NEC 10028326 Muscle disorders 10028302 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 29-May-2018 30-May-2018 Moderate 2 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 11481384 01147 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 7 exacerbation of shoulder pain Shoulder pain Shoulder pain 10040617 Musculoskeletal pain 10028391 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 07-Jun-2018 Moderate 2 Continuous 2 None 0 Persists, the Same 3 Not Related 0 11481384 01148 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 100000020280 01148 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 exacerbation of back pain Back pain aggravated Back pain aggravated 10048412 Back pain 10003988 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 25-May-2018 01-Jun-2018 Severe 3 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000020280 01149 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 100000034578 01149 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 exacerbation of shoulder pain Shoulder pain Shoulder pain 10040617 Musculoskeletal pain 10028391 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 11-May-2018 Moderate 2 Single/Intermittent 1 None 0 Persists, the Same 3 Not Related 0 100000034578 01149 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 craving for cannabis Drug craving Drug craving 10048481 Drug dependence 10013663 Substance-related disorders 10064465 Psychiatric disorders NEC 10037176 Psychiatric disorders 10037175 Not Serious 0 26-May-2018 20-Jun-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 100000034578 01150 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) Yes 1 100000056686 01151 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11529965 01151 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 throat irritation Throat irritation Throat irritation 10043521 Throat irritation 10043521 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 26-Mar-2018 12-May-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11529965 01151 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 forgetfulness Forgetfulness Forgetfulness 10017060 Memory impairment 10027175 Memory loss (excl dementia) 10027177 Mental impairment disorders 10057167 Nervous system disorders 10029205 Not Serious 0 30-Mar-2018 12-May-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11529965 01151 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 upper respiratory infection Upper respiratory infection Upper respiratory infection 10046300 Upper respiratory tract infection 10046306 Upper respiratory tract infections 10046309 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 06-May-2018 10-May-2018 Mild 1 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 11529965 01151 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 exacerbation of knee pain Knee pain Knee pain 10023477 Arthralgia 10003239 Joint related signs and symptoms 10023226 Joint disorders 10023213 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 18-May-2018 01-Jun-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11529965 01152 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) Yes 1 100000055699 01153 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11531070 01153 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 Throat Irritation Throat irritation Throat irritation 10043521 Throat irritation 10043521 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 28-Mar-2018 10-Apr-2018 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11531070 01153 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 increased awareness of musculoskeletal pain Musculoskeletal pain Musculoskeletal pain 10028391 Musculoskeletal pain 10028391 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 08-May-2018 08-May-2018 Moderate 2 Single/Intermittent 1 Withdrawn from Study Due to Adverse Event 3 Full Recovery/Return to Baseline 1 Probably Related 2 11531070 01153 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 sweating Sweating Sweating 10042661 Hyperhidrosis 10020642 Apocrine and eccrine gland disorders 10002982 Skin appendage conditions 10040798 Skin and subcutaneous tissue disorders 10040785 Not Serious 0 08-May-2018 08-May-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11531070 01153 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 exacerbation of anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 08-May-2018 12-May-2018 Moderate 2 Single/Intermittent 1 Withdrawn from Study Due to Adverse Event 3 Full Recovery/Return to Baseline 1 Probably Related 2 11531070 01153 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 emesis Emesis Emesis 10014542 Vomiting 10047700 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 08-May-2018 08-May-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11531070 01153 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 disorientation Disorientation Disorientation 10013395 Disorientation 10013395 Confusion and disorientation 10010301 Deliria (incl confusion) 10012221 Psychiatric disorders 10037175 Not Serious 0 08-May-2018 12-May-2018 Severe 3 Single/Intermittent 1 Withdrawn from Study Due to Adverse Event 3 Full Recovery/Return to Baseline 1 Probably Related 2 11531070 01153 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 7 unpleasant body high Feeling abnormal Feeling abnormal 10016322 Feeling abnormal 10016322 Feelings and sensations NEC 10068759 General system disorders NEC 10018073 General disorders and administration site conditions 10018065 Not Serious 0 08-May-2018 12-May-2018 Moderate 2 Single/Intermittent 1 Withdrawn from Study Due to Adverse Event 3 Full Recovery/Return to Baseline 1 Probably Related 2 11531070 01154 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11606851 01154 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 broken foot Broken foot Broken foot 10006385 Foot fracture 10016970 Lower limb fractures and dislocations 10024957 Bone and joint injuries 10005942 Injury, poisoning and procedural complications 10022117 Not Serious 0 21-Apr-2018 Moderate 2 Continuous 2 None 0 Persists, the Same 3 Not Related 0 11606851 01154 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 recurrence of syncopal episodes Syncopal attack Syncopal attack 10042771 Syncope 10042772 Disturbances in consciousness NEC 10013509 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 10-May-2018 10-May-2018 Moderate 2 Single/Intermittent 1 Withdrawn from Study Due to Adverse Event 3 Full Recovery/Return to Baseline 1 Not Related 0 11606851 01155 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11626198 01155 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 cough Cough Cough 10011224 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 05-Apr-2018 27-Apr-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11626198 01155 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 cough Cough Cough 10011224 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 14-May-2018 07-Jun-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11626198 01155 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 cough Cough Cough 10011224 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 22-Jun-2018 29-Jun-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11626198 01156 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11603890 01156 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 Headache Headache Headache 10019211 Headache 10019211 Headaches NEC 10019233 Headaches 10019231 Nervous system disorders 10029205 Not Serious 0 17-Apr-2018 18-Apr-2018 Mild 1 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Probably Related 2 11603890 01157 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 100000043307 01157 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 exacerbation of back pain Back pain aggravated Back pain aggravated 10048412 Back pain 10003988 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 25-May-2018 29-May-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000043307 01157 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 right leg numbness Numbness in leg Numbness in leg 10029839 Hypoaesthesia 10020937 Paraesthesias and dysaesthesias 10033788 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 24-May-2018 29-May-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000043307 01158 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11611561 01158 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 headache Headache Headache 10019211 Headache 10019211 Headaches NEC 10019233 Headaches 10019231 Nervous system disorders 10029205 Not Serious 0 23-Apr-2018 03-May-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11611561 01158 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 exacerbation of hand/wrist pain Hand pain Hand pain 10019116 Pain in extremity 10033425 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 21-May-2018 Moderate 2 Continuous 2 Prescription Medication 4 Persists, the Same 3 Not Related 0 11611561 01159 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11611652 01159 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 1 headache Headache Headache 10019211 Headache 10019211 Headaches NEC 10019233 Headaches 10019231 Nervous system disorders 10029205 Not Serious 0 02-May-2018 02-May-2018 Mild 1 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Possibly Related 1 11611652 01159 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 2 diarrhea Diarrhea Diarrhea 10012727 Diarrhoea 10012735 Diarrhoea (excl infective) 10012736 Gastrointestinal motility and defaecation conditions 10017977 Gastrointestinal disorders 10017947 Not Serious 0 14-May-2018 15-May-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11611652 01159 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 3 nausea Nausea Nausea 10028813 Nausea 10028813 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 14-May-2018 15-May-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11611652 01159 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 4 headache Headache Headache 10019211 Headache 10019211 Headaches NEC 10019233 Headaches 10019231 Nervous system disorders 10029205 Not Serious 0 26-May-2018 27-May-2018 Moderate 2 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 11611652 01159 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 5 exacerbation of light-headedness Dizziness aggravated Dizziness aggravated 10048324 Dizziness 10013573 Neurological signs and symptoms NEC 10029306 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 06-Jun-2018 06-Jun-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11611652 01159 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 6 nausea Nausea Nausea 10028813 Nausea 10028813 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 06-Jun-2018 06-Jun-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11611652 01159 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 8 7 sensation of heaviness Sensation of heaviness Sensation of heaviness 10040000 Discomfort 10013082 Pain and discomfort NEC 10033372 General system disorders NEC 10018073 General disorders and administration site conditions 10018065 Not Serious 0 06-Jun-2018 06-Jun-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11611652 01159 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 9 8 leg cramps Leg cramps Leg cramps 10024125 Muscle spasms 10028334 Muscle related signs and symptoms NEC 10028326 Muscle disorders 10028302 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 15-Jun-2018 18-Jun-2018 Mild 1 Single/Intermittent 1 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Possibly Related 1 11611652 01159 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 10 9 exacerbation of neuropathy Peripheral neuropathy aggravated Peripheral neuropathy aggravated 10034608 Neuropathy peripheral 10029331 Peripheral neuropathies NEC 10034607 Peripheral neuropathies 10034606 Nervous system disorders 10029205 Not Serious 0 17-Jul-2018 Moderate 2 Single/Intermittent 1 None 0 Persists, the Same 3 Possibly Related 1 11611652 01159 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 11 10 suicidal ideation Suicidal ideation Suicidal ideation 10042458 Suicidal ideation 10042458 Suicidal and self-injurious behaviour 10042459 Suicidal and self-injurious behaviours NEC 10042460 Psychiatric disorders 10037175 Not Serious 0 11-Jun-2018 11-Jun-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 11611652 01160 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 100000041653 01160 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 exacerbation of musculoskeletal pain Musculoskeletal pain Musculoskeletal pain 10028391 Musculoskeletal pain 10028391 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 29-May-2018 21-Jun-2018 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000041653 01160 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 tooth infection Tooth infection Tooth infection 10048762 Tooth infection 10048762 Dental and oral soft tissue infections 10012326 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 28-Jun-2018 18-Jul-2018 Mild 1 Continuous 2 Procedure or Therapy,Prescription Medication 1,4 Full Recovery/Return to Baseline 1 Not Related 0 100000041653 01160 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 throat irritation Throat irritation Throat irritation 10043521 Throat irritation 10043521 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 03-May-2018 25-May-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000041653 01160 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 throat irritation Throat irritation Throat irritation 10043521 Throat irritation 10043521 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 05-Jun-2018 27-Jun-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000041653 01160 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 dry mouth Dry mouth Dry mouth 10013781 Dry mouth 10013781 Oral dryness and saliva altered 10030975 Salivary gland conditions 10039404 Gastrointestinal disorders 10017947 Not Serious 0 05-Jun-2018 01-Jul-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000041653 01160 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 exacerbation of muscle spasms Muscle spasms Muscle spasms 10028334 Muscle spasms 10028334 Muscle related signs and symptoms NEC 10028326 Muscle disorders 10028302 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 28-Jun-2018 09-Jul-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000041653 01160 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 7 root canal Root canal procedure Root canal procedure 10051092 Endodontic procedure 10051085 Dental and gingival therapeutic procedures 10012317 Head and neck therapeutic procedures 10019190 Surgical and medical procedures 10042613 Not Serious 0 09-Jul-2018 09-Jul-2018 Moderate 2 Single/Intermittent 1 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 100000041653 01161 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11626197 01161 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 nausea Nausea Nausea 10028813 Nausea 10028813 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 07-May-2018 07-May-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11626197 01161 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 exacerbation of headache Headache aggravated Headache aggravated 10048567 Headache 10019211 Headaches NEC 10019233 Headaches 10019231 Nervous system disorders 10029205 Not Serious 0 06-May-2018 06-May-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11626197 01161 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 sensation of pressure around head Head pressure Head pressure 10019200 Head discomfort 10019194 Neurological signs and symptoms NEC 10029306 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 10-May-2018 22-Jul-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 11626197 01161 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 increased aggression Aggression aggravated Aggression aggravated 10001489 Aggression 10001488 Behaviour and socialisation disturbances 10004209 Personality disorders and disturbances in behaviour 10034726 Psychiatric disorders 10037175 Not Serious 0 21-May-2018 23-May-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 11626197 01161 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 dull/foggy feeling Foggy feeling in head Foggy feeling in head 10016876 Feeling abnormal 10016322 Feelings and sensations NEC 10068759 General system disorders NEC 10018073 General disorders and administration site conditions 10018065 Not Serious 0 28-May-2018 19-Jun-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11626197 01161 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 chest congestion Chest congestion Chest congestion 10008467 Respiratory tract congestion 10052251 Respiratory tract disorders NEC 10057184 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 17-Jun-2018 07-Jul-2018 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11626197 01161 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 7 sore throat Sore throat Sore throat 10041367 Oropharyngeal pain 10068319 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 18-Jun-2018 24-Jun-2018 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11626197 01161 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 8 8 foggy feeling Foggy feeling in head Foggy feeling in head 10016876 Feeling abnormal 10016322 Feelings and sensations NEC 10068759 General system disorders NEC 10018073 General disorders and administration site conditions 10018065 Not Serious 0 30-Jun-2018 22-Jul-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11626197 01161 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 9 9 weight gain Weight gain Weight gain 10047896 Weight increased 10047899 Physical examination procedures and organ system status 10071941 Physical examination and organ system status topics 10071940 Investigations 10022891 Not Serious 0 21-May-2018 Mild 1 Continuous 2 None 0 Persists, the Same 3 Possibly Related 1 11626197 01161 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 10 10 sore throat Sore throat Sore throat 10041367 Oropharyngeal pain 10068319 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 20-Jun-2018 21-Jun-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11626197 01162 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) Yes 1 100000225579 01163 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 11650339 01163 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 exacerbation of cough Cough aggravated Cough aggravated 10048381 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 22-May-2018 14-Jun-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11650339 01163 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 fall Fall Fall 10016173 Fall 10016173 Non-site specific injuries NEC 10029511 Injuries NEC 10022114 Injury, poisoning and procedural complications 10022117 Not Serious 0 22-May-2018 22-May-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11650339 01163 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 headache Headache Headache 10019211 Headache 10019211 Headaches NEC 10019233 Headaches 10019231 Nervous system disorders 10029205 Not Serious 0 31-May-2018 31-May-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 11650339 01163 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 heat exhaustion Heat exhaustion Heat exhaustion 10019332 Heat exhaustion 10019332 Heat injuries (excl thermal burns) 10019338 Injuries by physical agents 10022119 Injury, poisoning and procedural complications 10022117 Not Serious 0 02-Jul-2018 02-Jul-2018 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11650339 01163 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 heat exhaustion Heat exhaustion Heat exhaustion 10019332 Heat exhaustion 10019332 Heat injuries (excl thermal burns) 10019338 Injuries by physical agents 10022119 Injury, poisoning and procedural complications 10022117 Not Serious 0 09-Jul-2018 09-Jul-2018 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11650339 01163 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 exacerbation of musculoskeletal pain Musculoskeletal pain Musculoskeletal pain 10028391 Musculoskeletal pain 10028391 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 08-Jul-2018 10-Jul-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 11650339 01163 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 7 exacerbation of cough Cough aggravated Cough aggravated 10048381 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 10-Jul-2018 Moderate 2 Single/Intermittent 1 None 0 Persists, the Same 3 Possibly Related 1 11650339 01163 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 8 8 throat irritation Throat irritation Throat irritation 10043521 Throat irritation 10043521 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 08-Aug-2018 21-Aug-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 11650339 01164 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 100000041572 01164 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 exacerbation of anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 10-Jun-2018 14-Jun-2018 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 100000041572 01165 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 100000035120 01165 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 stomach discomfort Stomach discomfort Stomach discomfort 10042101 Abdominal discomfort 10000059 Gastrointestinal signs and symptoms NEC 10027678 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 11-Jun-2018 26-Jun-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 100000035120 01166 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 100000144128 01166 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 suicidal ideation Suicidal ideation Suicidal ideation 10042458 Suicidal ideation 10042458 Suicidal and self-injurious behaviour 10042459 Suicidal and self-injurious behaviours NEC 10042460 Psychiatric disorders 10037175 Not Serious 0 28-Jul-2018 28-Jul-2018 Mild 1 Single/Intermittent 1 Withdrawn from Study Due to Adverse Event 3 Full Recovery/Return to Baseline 1 Possibly Related 1 100000144128 01166 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 recurrence of anxiety Anxiety Anxiety 10002855 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 26-Jul-2018 01-Aug-2018 Moderate 2 Continuous 2 Withdrawn from Study Due to Adverse Event 3 Full Recovery/Return to Baseline 1 Possibly Related 1 100000144128 01166 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 recurrence of insomnia Insomnia Insomnia 10022437 Insomnia 10022437 Disturbances in initiating and maintaining sleep 10013510 Sleep disorders and disturbances 10040991 Psychiatric disorders 10037175 Not Serious 0 26-Jul-2018 01-Aug-2018 Moderate 2 Continuous 2 Withdrawn from Study Due to Adverse Event 3 Full Recovery/Return to Baseline 1 Possibly Related 1 100000144128 01167 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 100000081036 01167 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 1 abscess Abscess Abscess 10000269 Abscess 10000269 Infections NEC 10021902 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Serious 1 16-Jul-2018 19-Jul-2018 Severe 3 Continuous 2 Procedure or Therapy,Prescription Medication,Hospitalization 1,4,6 Full Recovery/Return to Baseline 1 Not Related 0 100000081036 01167 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 2 cellulitis Cellulitis Cellulitis 10007882 Cellulitis 10007882 Bacterial infections NEC 10004047 Bacterial infectious disorders 10004018 Infections and infestations 10021881 Not Serious 0 16-Jul-2018 28-Jul-2018 Moderate 2 Continuous 2 Prescription Medication 4 Full Recovery/Return to Baseline 1 Not Related 0 100000081036 01167 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 3 exacerbation of anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 03-Aug-2018 03-Aug-2018 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000081036 01167 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 4 throat irritation Throat irritation Throat irritation 10043521 Throat irritation 10043521 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 26-Jun-2018 25-Jul-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000081036 01167 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 5 exacerbation of depression Depression aggravated Depression aggravated 10012379 Depression 10012378 Depressive disorders 10012401 Depressed mood disorders and disturbances 10012375 Psychiatric disorders 10037175 Not Serious 0 03-Aug-2018 03-Aug-2018 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000081036 01167 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 6 exacerbation of nightmares Nightmares Nightmares 10029414 Nightmare 10029412 Parasomnias 10033920 Sleep disorders and disturbances 10040991 Psychiatric disorders 10037175 Not Serious 0 03-Aug-2018 03-Aug-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000081036 01167 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 8 7 surgical incision Surgical procedure Surgical procedure 10051332 Surgery 10042609 Therapeutic procedures NEC 10027700 Therapeutic procedures and supportive care NEC 10043413 Surgical and medical procedures 10042613 Not Serious 0 17-Jul-2018 01-Oct-2018 Moderate 2 Single/Intermittent 1 Procedure or Therapy,Prescription Medication 1,4 Full Recovery/Return to Baseline 1 Not Related 0 100000081036 01167 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 9 8 recurrence of abscess Abscess Abscess 10000269 Abscess 10000269 Infections NEC 10021902 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 13-Sep-2018 Moderate 2 Continuous 2 Procedure or Therapy 1 Persists, the Same 3 Not Related 0 100000081036 01167 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 10 9 rectal pain Rectal pain Rectal pain 10038072 Proctalgia 10036772 Anal and rectal pains 10002115 Anal and rectal conditions NEC 10002112 Gastrointestinal disorders 10017947 Not Serious 0 15-Jul-2018 19-Jul-2018 Severe 3 Continuous 2 Hospitalization 6 Full Recovery/Return to Baseline 1 Not Related 0 100000081036 01167 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 11 10 increased urinary frequency Increased urinary frequency Increased urinary frequency 10021692 Pollakiuria 10036018 Bladder and urethral symptoms 10004995 Urinary tract signs and symptoms 10046590 Renal and urinary disorders 10038359 Not Serious 0 15-Jul-2018 19-Jul-2018 Moderate 2 Single/Intermittent 1 Hospitalization 6 Full Recovery/Return to Baseline 1 Not Related 0 100000081036 01168 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 100000144067 01168 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 paranoia Paranoia Paranoia 10033864 Paranoia 10033864 Behaviour and socialisation disturbances 10004209 Personality disorders and disturbances in behaviour 10034726 Psychiatric disorders 10037175 Not Serious 0 02-Aug-2018 02-Aug-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000144067 01168 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 difficulty concentrating Concentration impaired Concentration impaired 10010249 Disturbance in attention 10013496 Mental impairment (excl dementia and memory loss) 10027375 Mental impairment disorders 10057167 Nervous system disorders 10029205 Not Serious 0 02-Aug-2018 23-Aug-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000144067 01168 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 headache Headache Headache 10019211 Headache 10019211 Headaches NEC 10019233 Headaches 10019231 Nervous system disorders 10029205 Not Serious 0 21-Aug-2018 21-Aug-2018 Mild 1 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Possibly Related 1 100000144067 01168 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 upper respiratory infection Upper respiratory infection Upper respiratory infection 10046300 Upper respiratory tract infection 10046306 Upper respiratory tract infections 10046309 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 03-Sep-2018 05-Sep-2018 Moderate 2 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 100000144067 01169 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 100000064245 01169 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 increased appetite Increased appetite Increased appetite 10021654 Increased appetite 10021654 Appetite disorders 10003022 Appetite and general nutritional disorders 10003018 Metabolism and nutrition disorders 10027433 Not Serious 0 12-Jul-2018 03-Aug-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000064245 01169 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 muscle soreness Muscle soreness Muscle soreness 10028332 Myalgia 10028411 Muscle pains 10028323 Muscle disorders 10028302 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 16-Jul-2018 Mild 1 Continuous 2 None 0 Persists, the Same 3 Not Related 0 100000064245 01169 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 cough Cough Cough 10011224 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 19-Jul-2018 03-Aug-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000064245 01169 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 hand tremor Tremor of hands Tremor of hands 10044577 Tremor 10044565 Tremor (excl congenital) 10044566 Movement disorders (incl parkinsonism) 10028037 Nervous system disorders 10029205 Not Serious 0 15-Jul-2018 Moderate 2 Continuous 2 None 0 Persists, the Same 3 Not Related 0 100000064245 01169 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 exacerbation of anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 20-Jul-2018 17-Aug-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 100000064245 01169 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 exacerbation of nightmares Nightmares Nightmares 10029414 Nightmare 10029412 Parasomnias 10033920 Sleep disorders and disturbances 10040991 Psychiatric disorders 10037175 Not Serious 0 14-Jul-2018 17-Aug-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 100000064245 01169 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 7 exacerbation of depression Depression aggravated Depression aggravated 10012379 Depression 10012378 Depressive disorders 10012401 Depressed mood disorders and disturbances 10012375 Psychiatric disorders 10037175 Not Serious 0 09-Sep-2018 22-Sep-2018 Severe 3 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000064245 01169 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 8 8 exacerbation of anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 09-Sep-2018 22-Sep-2018 Severe 3 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000064245 01169 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 9 9 exacerbation of insomnia Insomnia exacerbated Insomnia exacerbated 10022440 Insomnia 10022437 Disturbances in initiating and maintaining sleep 10013510 Sleep disorders and disturbances 10040991 Psychiatric disorders 10037175 Not Serious 0 09-Sep-2018 22-Sep-2018 Severe 3 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 100000064245 01169 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 10 10 exacerbation of panic attacks Panic attacks Panic attacks 10033665 Panic attack 10033664 Panic attacks and disorders 10068300 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 09-Sep-2018 22-Sep-2018 Severe 3 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000064245 01169 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 12 11 emotional distress Emotional distress Emotional distress 10049119 Emotional distress 10049119 Emotional and mood disturbances NEC 10014556 Mood disorders and disturbances NEC 10027946 Psychiatric disorders 10037175 Not Serious 0 18-Jul-2018 24-Jul-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000064245 01170 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 100000079524 01170 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 nausea Nausea Nausea 10028813 Nausea 10028813 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 12-Jul-2018 12-Jul-2018 Severe 3 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000079524 01170 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 dizziness Dizziness Dizziness 10013573 Dizziness 10013573 Neurological signs and symptoms NEC 10029306 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 12-Jul-2018 12-Jul-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000079524 01170 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 closed eye hallucinations Visual hallucinations Visual hallucinations 10047570 Hallucination, visual 10019075 Perception disturbances 10034374 Disturbances in thinking and perception 10013511 Psychiatric disorders 10037175 Not Serious 0 12-Jul-2018 12-Jul-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000079524 01170 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 paranoia Paranoia Paranoia 10033864 Paranoia 10033864 Behaviour and socialisation disturbances 10004209 Personality disorders and disturbances in behaviour 10034726 Psychiatric disorders 10037175 Not Serious 0 12-Jul-2018 12-Jul-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000079524 01170 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 numbness in face Numbness in face Numbness in face 10029836 Hypoaesthesia 10020937 Paraesthesias and dysaesthesias 10033788 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 12-Jul-2018 12-Jul-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000079524 01170 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 nausea Nausea Nausea 10028813 Nausea 10028813 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 13-Jul-2018 03-Aug-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000079524 01170 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 7 dizziness Dizziness Dizziness 10013573 Dizziness 10013573 Neurological signs and symptoms NEC 10029306 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 23-Jul-2018 23-Jul-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000079524 01170 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 8 8 fall Fall Fall 10016173 Fall 10016173 Non-site specific injuries NEC 10029511 Injuries NEC 10022114 Injury, poisoning and procedural complications 10022117 Not Serious 0 05-Sep-2018 05-Sep-2018 Moderate 2 Single/Intermittent 1 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 100000079524 01170 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 9 9 exacerbation of back pain Back pain aggravated Back pain aggravated 10048412 Back pain 10003988 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 01-Nov-2018 14-Nov-2018 Moderate 2 Continuous 2 Prescription Medication 4 Full Recovery/Return to Baseline 1 Not Related 0 100000079524 01170 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 10 10 exacerbation of neck pain Neck pain Neck pain 10028836 Neck pain 10028836 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 05-Sep-2018 Moderate 2 Single/Intermittent 1 Non-prescription Medication 5 Persists, the Same 3 Not Related 0 100000079524 01170 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 11 11 exacerbation of anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 10-Aug-2018 10-Sep-2018 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000079524 01170 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 12 12 exacerbation of back pain Back pain aggravated Back pain aggravated 10048412 Back pain 10003988 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 10-Aug-2018 18-Aug-2018 Moderate 2 Continuous 2 Prescription Medication 4 Full Recovery/Return to Baseline 1 Not Related 0 100000079524 01171 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 100000081616 01171 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 dry eyes Dry eyes Dry eyes 10013778 Dry eye 10013774 Lacrimation disorders 10072989 Eye disorders NEC 10015917 Eye disorders 10015919 Not Serious 0 20-Jul-2018 20-Jul-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000081616 01171 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 drowsiness Drowsiness Drowsiness 10013649 Somnolence 10041349 Disturbances in consciousness NEC 10013509 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 23-Aug-2018 15-Sep-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000081616 01171 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 lower back nerve ablation Therapeutic nerve ablation Therapeutic nerve ablation 10070755 Therapeutic nerve ablation 10070755 Therapeutic procedures NEC 10027700 Therapeutic procedures and supportive care NEC 10043413 Surgical and medical procedures 10042613 Not Serious 0 21-Sep-2018 22-Sep-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000081616 01172 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) Yes 1 100000202905 01173 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 100000089428 01173 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 Constipation Constipation Constipation 10010774 Constipation 10010774 Gastrointestinal atonic and hypomotility disorders NEC 10017933 Gastrointestinal motility and defaecation conditions 10017977 Gastrointestinal disorders 10017947 Not Serious 0 06-Aug-2018 07-Aug-2018 Mild 1 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 100000089428 01173 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 increased appetite Increased appetite Increased appetite 10021654 Increased appetite 10021654 Appetite disorders 10003022 Appetite and general nutritional disorders 10003018 Metabolism and nutrition disorders 10027433 Not Serious 0 30-Jul-2018 25-Aug-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000089428 01173 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 Fainting Fainting Fainting 10016169 Syncope 10042772 Disturbances in consciousness NEC 10013509 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 11-Sep-2018 11-Sep-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000089428 01173 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 upper respiratory infection Upper respiratory infection Upper respiratory infection 10046300 Upper respiratory tract infection 10046306 Upper respiratory tract infections 10046309 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 22-Sep-2018 26-Sep-2018 Mild 1 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 100000089428 01173 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 diarrhea Diarrhea Diarrhea 10012727 Diarrhoea 10012735 Diarrhoea (excl infective) 10012736 Gastrointestinal motility and defaecation conditions 10017977 Gastrointestinal disorders 10017947 Not Serious 0 25-Sep-2018 28-Sep-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000089428 01173 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 6 emesis Emesis Emesis 10014542 Vomiting 10047700 Nausea and vomiting symptoms 10028817 Gastrointestinal signs and symptoms 10018012 Gastrointestinal disorders 10017947 Not Serious 0 25-Sep-2018 27-Sep-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000089428 01174 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 100000089425 01174 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 throat irritation Throat irritation Throat irritation 10043521 Throat irritation 10043521 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 06-Aug-2018 06-Aug-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000089425 01175 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 100000149259 01175 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 throat irritation Throat irritation Throat irritation 10043521 Throat irritation 10043521 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 14-Aug-2018 22-Sep-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000149259 01175 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 ear infection Ear infection Ear infection 10014011 Ear infection 10014011 Ear infections 10014013 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 03-Sep-2018 Mild 1 Continuous 2 Procedure or Therapy,Prescription Medication 1,4 Persists, Diminishing 2 Not Related 0 100000149259 01175 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 light-headedness Light headedness Light headedness 10024461 Dizziness 10013573 Neurological signs and symptoms NEC 10029306 Neurological disorders NEC 10029305 Nervous system disorders 10029205 Not Serious 0 28-Sep-2018 30-Sep-2018 Severe 3 Single/Intermittent 1 Other (specify) 8 discontinued buspirone Full Recovery/Return to Baseline 1 Not Related 0 100000149259 01175 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 increased appetite Increased appetite Increased appetite 10021654 Increased appetite 10021654 Appetite disorders 10003022 Appetite and general nutritional disorders 10003018 Metabolism and nutrition disorders 10027433 Not Serious 0 14-Oct-2018 15-Nov-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000149259 01175 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 suicidal ideation Suicidal ideation Suicidal ideation 10042458 Suicidal ideation 10042458 Suicidal and self-injurious behaviour 10042459 Suicidal and self-injurious behaviours NEC 10042460 Psychiatric disorders 10037175 Not Serious 0 21-Nov-2018 21-Nov-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000149259 01176 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 100000152731 01176 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 sinus infection Sinus infection Sinus infection 10040745 Sinusitis 10040753 Upper respiratory tract infections 10046309 Infections - pathogen unspecified 10021879 Infections and infestations 10021881 Not Serious 0 16-Sep-2018 25-Sep-2018 Moderate 2 Continuous 2 Prescription Medication,Non-prescription Medication 4,5 Full Recovery/Return to Baseline 1 Not Related 0 100000152731 01176 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 cough Cough Cough 10011224 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 01-Oct-2018 01-Oct-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 100000152731 01176 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 exacerbation of anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 12-Nov-2018 16-Nov-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000152731 01176 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 mood disturbance Mood change Mood change 10027941 Mood altered 10027940 Emotional and mood disturbances NEC 10014556 Mood disorders and disturbances NEC 10027946 Psychiatric disorders 10037175 Not Serious 0 06-Oct-2018 21-Oct-2018 Moderate 2 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000152731 01177 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 100000144065 01177 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 wisdom tooth eruption No adverse event No adverse event 10067482 No adverse event 10067482 Adverse effect absent 10001424 General system disorders NEC 10018073 General disorders and administration site conditions 10018065 Not Serious 0 07-Sep-2018 23-Oct-2018 Mild 1 Continuous 2 Procedure or Therapy,Non-prescription Medication 1,5 Full Recovery/Return to Baseline 1 Not Related 0 100000144065 01177 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 dental fillings Dental fillings Dental fillings 10012323 Tooth repair 10044051 Dental and gingival therapeutic procedures 10012317 Head and neck therapeutic procedures 10019190 Surgical and medical procedures 10042613 Not Serious 0 18-Sep-2018 18-Sep-2018 Moderate 2 Single/Intermittent 1 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 100000144065 01177 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 3 tooth pain Tooth pain Tooth pain 10059723 Toothache 10044055 Dental pain and sensation disorders 10044049 Dental and gingival conditions 10044018 Gastrointestinal disorders 10017947 Not Serious 0 18-Sep-2018 08-Oct-2018 Mild 1 Continuous 2 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Not Related 0 100000144065 01177 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 4 cough Cough Cough 10011224 Cough 10011224 Coughing and associated symptoms 10011233 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 03-Oct-2018 05-Oct-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000144065 01177 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 6 5 post-surgery pain--wisdom tooth removal Post procedural pain Post procedural pain 10049749 Procedural pain 10064882 Non-site specific procedural complications 10029559 Procedural related injuries and complications NEC 10069888 Injury, poisoning and procedural complications 10022117 Not Serious 0 23-Oct-2018 03-Nov-2018 Moderate 2 Continuous 2 Prescription Medication,Non-prescription Medication 4,5 Full Recovery/Return to Baseline 1 Not Related 0 100000144065 01177 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 7 6 wisdom tooth removal Wisdom teeth removal Wisdom teeth removal 10047991 Wisdom teeth removal 10047991 Dental and gingival therapeutic procedures 10012317 Head and neck therapeutic procedures 10019190 Surgical and medical procedures 10042613 Not Serious 0 23-Oct-2018 23-Oct-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000144065 01178 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 100000144066 01178 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 headache Headache Headache 10019211 Headache 10019211 Headaches NEC 10019233 Headaches 10019231 Nervous system disorders 10029205 Not Serious 0 06-Sep-2018 06-Sep-2018 Mild 1 Continuous 2 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 100000144066 01178 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 exacerbation of anxiety Exacerbation of anxiety Exacerbation of anxiety 10015574 Anxiety 10002855 Anxiety symptoms 10002869 Anxiety disorders and symptoms 10002861 Psychiatric disorders 10037175 Not Serious 0 17-Oct-2018 17-Oct-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Possibly Related 1 100000144066 01178 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 headache Headache Headache 10019211 Headache 10019211 Headaches NEC 10019233 Headaches 10019231 Nervous system disorders 10029205 Not Serious 0 30-Oct-2018 31-Oct-2018 Mild 1 Single/Intermittent 1 Non-prescription Medication 5 Full Recovery/Return to Baseline 1 Possibly Related 1 100000144066 01178 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 headache Headache Headache 10019211 Headache 10019211 Headaches NEC 10019233 Headaches 10019231 Nervous system disorders 10029205 Not Serious 0 01-Nov-2018 30-Nov-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000144066 01178 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 5 5 paranoia Paranoia Paranoia 10033864 Paranoia 10033864 Behaviour and socialisation disturbances 10004209 Personality disorders and disturbances in behaviour 10034726 Psychiatric disorders 10037175 Not Serious 0 04-Sep-2018 04-Sep-2018 Moderate 2 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000144066 01179 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 100000141740 01179 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 throat irritation Throat irritation Throat irritation 10043521 Throat irritation 10043521 Upper respiratory tract signs and symptoms 10046313 Respiratory disorders NEC 10038716 Respiratory, thoracic and mediastinal disorders 10038738 Not Serious 0 11-Sep-2018 03-Oct-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000141740 01179 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 increased appetite Increased appetite Increased appetite 10021654 Increased appetite 10021654 Appetite disorders 10003022 Appetite and general nutritional disorders 10003018 Metabolism and nutrition disorders 10027433 Not Serious 0 15-Oct-2018 05-Nov-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000141740 01179 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 3 3 hazy feeling Feeling dazed Feeling dazed 10050462 Feeling abnormal 10016322 Feelings and sensations NEC 10068759 General system disorders NEC 10018073 General disorders and administration site conditions 10018065 Not Serious 0 18-Oct-2018 05-Nov-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Probably Related 2 100000141740 01179 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 4 4 weight loss Weight loss Weight loss 10047900 Weight decreased 10047895 Physical examination procedures and organ system status 10071941 Physical examination and organ system status topics 10071940 Investigations 10022891 Not Serious 0 30-Sep-2018 01-Dec-2018 Mild 1 Single/Intermittent 1 None 0 Full Recovery/Return to Baseline 1 Not Related 0 100000141740 01180 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) No 0 100000229276 01180 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 1 1 exacerbation of back pain Back pain aggravated Back pain aggravated 10048412 Back pain 10003988 Musculoskeletal and connective tissue pain and discomfort 10068757 Musculoskeletal and connective tissue disorders NEC 10028393 Musculoskeletal and connective tissue disorders 10028395 Not Serious 0 10-Oct-2018 Severe 3 Continuous 2 None 0 Persists, the Same 3 Not Related 0 100000229276 01180 Site 01: (SRI) Phoenix, Arizona USA Enrolled Logs Adverse Events (AE) 2 2 suicidal ideation Suicidal ideation Suicidal ideation 10042458 Suicidal ideation 10042458 Suicidal and self-injurious behaviour 10042459 Suicidal and self-injurious behaviours NEC 10042460 Psychiatric disorders 10037175 Not Serious 0 10-Dec-2018 Mild 1 Single/Intermittent 1 Other (specify) 8 regular contact w/ study MD Persists, Diminishing 2 Not Related 0 100000229276