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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Experimental 1: All Nations Breath of Life Program (ANBL) | All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into either the culturally-tailored "All Nations Breath of Life" program (ANBL) or Nontailored program (NT). Experimental 1: All Nations Breath of Life program (ANBL): ANBL consists of in-person group sessions and individual telephone calls. We have successfully conducted a pilot study of ANBL and have found very promising results. At six months and 12 months post baseline, all participants will be assessed for smoking status and smoking abstinence. Pharmacotherapy (e.g. Varenicline or Bupropion or NRT): Pharmacotherapy (e.g. Varenicline or Bupropion or NRT) | 0 | None | 0 | 243 | 7 | 243 | View |
| Experimental 2: Nontailored Program (NT) | All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into either the culturally-tailored "All Nations Breath of Life" program (ANBL) or Nontailored program (NT). Experimental 2: Nontailored program (NT): The nontailored intervention includes the medicines listed above to all participants and targeted counseling delivered by non-American Indian counselors who have worked closely with the American Indian communities and respect the cultures, values, and traditions of the Indian people. Therefore, our intervention includes the current "best practice" recommendations for smoking cessation. At six months and 12 months post baseline, all participants will be assessed for smoking status and smoking abstinence. Pharmacotherapy (e.g. Varenicline or Bupropion or NRT): Pharmacotherapy (e.g. Varenicline or Bupropion or NRT) | 2 | None | 0 | 220 | 8 | 220 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Sleep disturbance | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Upset stomach | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Elevated blood pressure | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Aggressiveness and irritability | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Skin reactions | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chest pressure | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |