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 |
|---|---|---|---|---|---|---|---|---|
| Open-Label Sarilumab (Pre-randomization) | On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks. | 0 | None | 1 | 15 | 9 | 15 | View |
| Double-Blind Sarilumab (Post-randomization) | After completing the open-label period, participants are randomized to receive sarilumab every two weeks for 12 weeks. | 0 | None | 0 | 2 | 1 | 2 | View |
| Double-Blind Placebo (Post-randomization) | After completing the open-label period, participants are randomized receive placebo every two weeks for 12 weeks. | 0 | None | 0 | 8 | 5 | 8 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Transaminitis | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Prolonged neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Ulcers aphthous oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Peripheral vision defective | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Shortness of breath | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Cervical radiculopathy | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Kappa light chain analysis increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Herniated disc | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Creatinine kinase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hyperbilirubinemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Pain in (r) hip | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Alcohol rehabilitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |