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 |
|---|---|---|---|---|---|---|---|---|
| SABR Plus Pembrolizumab | SABR (18-20Gy) to 1-3 lesions followed 7 (+/-2) days later by pembrolizumab 200mg every 3 weeks for 24 months. | 1 | None | 2 | 5 | 0 | 5 | View |
| Pembrolizumab Plus SABR | Pembrolizumab 200mg every 3 weeks for 24 months with SABR (18-20Gy) to 1-3 lesions delivered 7 (+/-2) days after first dose of Pembrolizumab. | 4 | None | 3 | 8 | 0 | 8 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cortical thinning | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Reaccumulation of pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Non ST elevation myocardial infarct | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hip pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Diabetic ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |