Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-25 @ 2:30 PM
NCT ID:
NCT03722966
Description:
None
Frequency Threshold:
0
Time Frame:
27 weeks (1-week pre-quit through 26 weeks post-quit)
Study:
NCT03722966
Study Brief:
Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Varenicline/Counseling + Med Reminders (VAR+REM) | Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, and automated medication reminders via their smartphones. Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence. Medication Reminders: Half of study participants will be randomly assigned to receive automated medication reminders via their smartphones. Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist. | 0 | None | 0 | 2 | 0 | 2 | View |
| Varenicline/Counseling (VAR+NREM) | Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, and no automated medication reminders. Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence. Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist. | 0 | None | 0 | 12 | 3 | 12 | View |
| Varenicline/Counseling + Oral NRT (VAR+NRT+NREM) | Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, 12 weeks of oral nicotine replacement therapy (NRT; gum or lozenge), and no automated medication reminders. Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence. Oral Nicotine Replacement Therapy (NRT): Half of study participants will be randomly assigned to receive oral nicotine replacement therapy (4mg gum or 4mg lozenge, depending on preference; to be used every 1-2 hours as urges occur) in addition to varenicline. Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist. | 0 | None | 0 | 11 | 3 | 11 | View |
| Varenicline/Counseling + Oral NRT + Med Reminders (VAR+NRT+REM) | Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, 12 weeks of oral nicotine replacement therapy (NRT; gum or lozenge), and automated medication reminders via their smartphones. Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence. Oral Nicotine Replacement Therapy (NRT): Half of study participants will be randomly assigned to receive oral nicotine replacement therapy (4mg gum or 4mg lozenge, depending on preference; to be used every 1-2 hours as urges occur) in addition to varenicline. Medication Reminders: Half of study participants will be randomly assigned to receive automated medication reminders via their smartphones. Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist. | 0 | None | 0 | 9 | 3 | 9 | View |
Serious Events(If Any):
Other Events(If Any):