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 |
|---|---|---|---|---|---|---|---|---|
| Cohort 1: NSCLC Monotherapy | Progressive disease on 1st line monotherapy anti-PD-1/-L1. | 0 | None | 0 | 1 | 0 | 1 | View |
| Cohort 7: gBRCAm HER2- Adenocarcinoma of the Breast | Progressive disease on a PARP inhibitor monotherapy in participants previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. | 0 | None | 0 | 1 | 0 | 1 | View |
| Cohort 5: Castrate-resistant Adenocarcinoma of the Prostate | Progressive disease on enzalutamide monotherapy. | 0 | None | 0 | 5 | 1 | 5 | View |
| Cohort 2: NSCLC Combination | Progressive disease on 1st line anti-PD-1/-L1 plus standard doublet platinum-containing regimen; or progressive disease on 1st line anti-PD-1/-L1 plus standard doublet platinum-containing regimen followed by continuation of single agent anti-PD-1/-L1. | 0 | None | 0 | 4 | 0 | 4 | View |
| Cohort 3: RCC With Clear Cell Component | Progressive disease on 2nd line monotherapy anti-PD-1/-L1; or progressive disease on 1st line combination of doublet anti-PD-1/-L1 with anti-CTLA-4; or progressive disease on 1st line combination of avelumab with axitinib or pembrolizumab with axitinib. | 0 | None | 0 | 5 | 0 | 5 | View |
| Cohort 4: HR+ HER2- Adenocarcinoma of the Breast | Progressive disease on 1st line combination of doublet palbociclib with hormonal therapy. | 0 | None | 0 | 10 | 1 | 10 | View |
| Cohort 6: Castrate-resistant Adenocarcinoma of the Prostate | Progressive disease on abiraterone in combination with prednisone. | 0 | None | 0 | 10 | 0 | 10 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Post procedural contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.1 | View |
| Dermatitis contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.1 | View |