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 |
|---|---|---|---|---|---|---|---|---|
| Imsidolimab | Participants received imsidolimab 750 mg intravenously on Day 1 followed by administration of 3 doses of subcutaneous imsidolimab 100 mg on Days 29, 57, and 85. | 0 | None | 2 | 8 | 6 | 8 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.1) | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.1) | View |
| Blood folate decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| White blood cell count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Skin haemorrhage | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Mitral valve prolapse | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| Myxomatous mitral valve degeneration | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Swelling face | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.1) | View |
| Vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.1) | View |