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 |
|---|---|---|---|---|---|---|---|---|
| Arm A - Tadalafil 10mg | Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity. Tadalafil: Given orally | None | None | 1 | 15 | 3 | 15 | View |
| Arm B - Tadalafil 20mg | Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity. Tadalafil: Given orally | None | None | 2 | 15 | 8 | 15 | View |
| Arm C - Placebo | Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity. Placebo: Given orally | None | None | 0 | 5 | 3 | 5 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache - Grade 2 | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Neck Pain - Grade 2 | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Pain in Extremity - Grade 2 | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Back Pain - Grade 1 | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Constipation - Grade 1 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Ear Nose Throat Examination abnormal | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (4.0) | View |
| Neck Pain - Grade 1 | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Sexual - Grade 1 | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| Back Pain - Grade 2 | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Cough - Grade 1 | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Diarrhea - Grade 1 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Headache - Grade 1 | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Pain in Extremity - Grade 1 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Pulmonary - Grade 1 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |