Supplementary material 12 to: Electronic cigarettes for smoking cessation

Lindson N, Livingstone-Banks J, Butler AR, McRobbie H, Bullen CR, Hajek P, Wu AD, Begh R, Theodoulou A, Notley C, Rigotti NA, Turner T, Fanshawe T, Hartmann-Boyce J
https://doi.org/10.1002/14651858.CD010216.pub10

The material in this section has been supplied by the author(s) for publication under a Licence for Publication and the author(s) are solely responsible for the material. Cochrane has reviewed this material, but Cochrane has not copyedited, formatted or proofread. Cochrane accordingly gives no representations or warranties of any kind in relation to, and accepts no liability for any reliance on or use of, such material.

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Serious adverse events data not contributing to meta-analyses

Study ID

Study design

Intervention/ comparator

Time point

Data (SAEs)

Between group difference (RCT) (↑

more SAEs in intervention arm; ↔ equivocal; ↓ fewer SAEs in intervention arm)

Direction over time (cohort) (↓ decline in frequency)

Edwards 2023

Cohort

Nicotine EC

6 months

No serious adverse events or expeditable events occurred.

Bullen 2013

RCT

Nicotine EC v non-nicotine EC v NRT

6 months

None occurred which were considered related to study treatment. No further information available.

Caponnetto 2013b*

Cohort

Nicotine EC

1 year

None occurred

Caponnetto 2021*

Cohort

Nicotine EC

24 weeks

None occurred

Hickling 2019

Cohort

Nicotine EC

6 weeks

(Recruited from mental health settings) Five SAEs during study; all were psychiatric hospitalisations; all were considered unrelated to the study intervention

Higgins 2024

RCT

nicotine EC + very low nicotine content cigarettes (VLNC) v VLNC

16 weeks

One SAE related or probably related to study product in EC plus VLNC arm. None in VLNC alone arm.

Humair 2014

Cohort

Nicotine EC

Unclear (longest follow-up 1 year)

None reported

Dawkins 2020

RCT

Nicotine EC v usual care

24 weeks

Not formally assessed. A&E visits reported: “low but constant use of emergency and hospital services in both arms. Usual care (n= 32), 4-7 participants visited A & E at different time points. The number of visits ranged from one to nine times. In the EC arm (n =48), 5-7 participants visited A & E at different time points. The number of visits ranged from one to six times.”

“in the UC arm, at least five participants at baseline, two at 4 weeks, one at 12 weeks and one at 24 weeks were admitted following the A & E visit. In the EC arm, at least two participants at baseline, three at 4 weeks, and one at 12 weeks were admitted following the A & E visit.”

Kanobe 2022*

Cohort

Nicotine EC

None reported

Morris 2022*

RCT

Nicotine EC, variations on nicotine strength, flavour, and salt vs. freebase

9 days

None occurred

NCT02648178

Cohort

Nicotine EC

NS

Reports 1 event (death) (n = 19). No further detail provided.

Polosa 2011*

Cohort

Nicotine EC

6 months

None occurred during the study

Sifat 2024

RCT

Nicotine EC v nicotine EC + incentives

8 weeks

None reported

Valentine 2018

Cohort

Nicotine EC

8 weeks

“No serious adverse events were reported”