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 |
|---|---|---|---|---|---|---|---|---|
| Test A + Training Test A | Test Product A was used both during part one of the study (Test A) and part two (Training Test A) hence adverse events are reported collectively for Test Product A. Consequently, Test Product A is used for two periods compared to Standard care which has been used for only one. | None | None | 0 | 22 | 8 | 22 | View |
| Test B + Training Test B | Test Product B was used both during part one of the study (Test B) and part two (Training Test B) hence adverse events are reported collectively for Test Product B. Consequently, Test Product B is used for two periods compared to Standard care which has been used for only one. | None | None | 0 | 22 | 9 | 22 | View |
| Standard Care | Standard care was used only during part one of the study. i.e. for one period only. | None | None | 0 | 22 | 3 | 22 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cold or influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Planned operation, non-study related | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Herpes Zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Diarrhea or constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Peristomal skin irritation/broken skin/stomal bleeding | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pain, leg | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |