Skip to main content

Table 3 Reported and observed adverse events* (subjects randomized smoking and used smoking cessation medication) and Columbia Suicide Severity Rating Scale (C-SSRS) assessments

From: A pragmatic, randomized, controlled study evaluating the impact of access to smoking cessation pharmacotherapy coverage on the proportion of successful quitters in a Canadian population of smokers motivated to quit (ACCESSATION)

All-causality AEs, n(%)

Full coverage (n = 682)

No coverage (n = 435)

Total number of AEs

1473

830

Total number of participants with AEs

451 (66.1)

271 (62.3)

Subjects who discontinued study due to AE

6 (0.9)

0

Subjects with SAEs

35 (5.1)

18 (4.1)

Subjects with severe AEs

57 (8.4)

32 (7.4)

  1. AE = adverse event; SAE = serious adverse event.
  2. *All observed or volunteered AEs, regardless of smoking cessation method, or selected or suspected causal relationship, were reported. For all AEs, the investigator was required to pursue and obtain information adequate both to determine the outcome of the AE and to assess whether it met the criteria for classification as a serious AE.
  3. The C–SSRS was part of the neuropsychiatric section of the medical history at screening/randomization and was administered to all subjects at given visits and at the investigator’s discretion to assist with safety reporting and evaluation of possible suicide-related AEs. A “yes” answer for suicidal ideation and/or behavior was observed in 25 (3.7%) and 11 (2.5%) in the full coverage and no coverage groups, respectively (all-randomized and treated population). A suicidal attempt was reported in one subject who did not take smoking cessation medication.