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 @ 6:52 PM
Ignite Modification Date:
2025-12-25 @ 4:24 PM
NCT ID:
NCT04490057
Description:
None
Frequency Threshold:
0
Time Frame:
Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
Study:
NCT04490057
Study Brief:
A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Stage 2: Varenicline or Bupropion + CM | Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2) | 0 | None | 3 | 60 | 3 | 60 | View |
| Stage 2: NRT+CM Plus | Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2). | 0 | None | 3 | 62 | 2 | 62 | View |
| Stage 1: NRT | Stage 1: participants randomized to receive nicotine replacement therapy only in Weeks 0-12 | 1 | None | 13 | 163 | 6 | 163 | View |
| Stage 1: NRT+CM | Participants randomized to receive nicotine replacement therapy and contingency management (Weeks 0-12) | 2 | None | 9 | 160 | 14 | 160 | View |
| Stage 2: Varenicline or Bupropion | Non-responders to NRT in Stage 1 were switched to varenicline or bupropion alone for second 12 weeks (Stage 2). | 0 | None | 5 | 70 | 2 | 70 | View |
| Stage 2: NRT+CM | Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2). | 1 | None | 4 | 74 | 0 | 74 | View |
| Stage 2: NRT Responders | Responders from Stage 1 remain on nicotine replacement therapy for Stage 2 | 0 | None | 1 | 16 | 0 | 16 | View |
| Stage 2: NRT+CM Responders | Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2). | 0 | None | 1 | 36 | 1 | 36 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrointestinal (nausea, diarrhea, abdominal pain) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Infection - pathogen unspecified | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Joint pain or connective tissue disorder | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Liver injury or dysfunction | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Neurological disorders (sedation, lethargy, dizziness) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Respiratory disorders including pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Altered mental status | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Alcohol withdrawal | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | None | View |
| Kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Other | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | None | View |
| Suicidality | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Cardiac illness or injury | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrointestinal Gastrointestinal (nausea, diarrhea, abdominal pain) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Joint pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Liver injury or dysfunction | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Respiratory disorders including pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Psychiatric issues | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Cardiac illness or injury | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Reaction to nicotine replacement therapy | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |