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 @ 7:57 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
NCT ID:
NCT01120704
Description:
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
Frequency Threshold:
5
Time Frame:
AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Study:
NCT01120704
Study Brief:
Evaluation of Treatments to Improve Smoking Cessation Medication Adherence
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 26 Weeks of Nicotine Patch and Nicotine Gum | Participants randomized to this condition received 26 Weeks of Nicotine Patch and Nicotine Gum. IF the participant smoked \>10 cigs/day AND is randomized to a 26 week medication condition: they were asked to take one 21 mg patch per day for 22 weeks, THEN one 14 mg patch per day for 2 weeks, THEN one patch 7 mg patch per day for 2 weeks. Participants were also asked to use one piece of one 4-mg- gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment. IF the participant smoked 5-10 cigs/day AND is randomized to a 26 week medication condition: they were asked to take one 14 mg patch per day for 22 weeks, THEN one patch 7 mg patch per day for 4 weeks. Participants were also asked to use one piece of 2-mg gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication | None | None | 10 | 275 | 146 | 275 | View |
| 8 Weeks of Nicotine Patch and Nicotine Gum | Participants randomized to this condition received 8 Weeks of Nicotine Patch and Nicotine Gum. IF participant smoked \>10 cigs/day AND is randomized to a 8 week condition: they were asked to take one 21 mg patch/day for 4 weeks, THEN one 14 mg patch/day for 2 weeks, THEN one patch 7mg/day for 2 weeks.Participants were also asked to use 4-mg gum every 1-2 hours (9 pieces maximum per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment. IF participant smoked 5-10 cigs/day AND is randomized to the 8 week medication condition: they were asked to take one 14 mg patch/day for 4 weeks, THEN one 7 mg patch/day for 4 weeks. Participants were also asked to use 2-mg gum every 1-2 hours (9 pieces max per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment. | None | None | 6 | 269 | 141 | 269 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiovascular | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pulmonary | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Gastrointestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Musculoskeletal | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Death-unknown cause | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Indigestion | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Itches or Hives | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Mouth Problems | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Skin Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| VividDreams | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |