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
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Amlexanox | Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks Amlexanox | 0 | None | 1 | 21 | 15 | 21 | View |
| Placebo | Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks Placebo | 0 | None | 1 | 21 | 16 | 21 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Indigestion | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Head cold | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Skin rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Worsening neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Ankle edema | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Elevated CK | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Itchy skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |