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 |
|---|---|---|---|---|---|---|---|---|
| Experimental | hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX: Methotrexate (oral administration) Folic Acid: Folic Acid (oral administration) Loxoprofen: Loxoprofen (oral administration) | 11 | None | 2 | 23 | 9 | 23 | View |
| Placebo Comparator | hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection) MTX: Methotrexate (oral administration) Folic Acid: Folic Acid (oral administration) Loxoprofen: Loxoprofen (oral administration) | 9 | None | 1 | 24 | 8 | 24 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hospitalized not related to RA | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| gastrointestinal disorders | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hepatic enzyme increased | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Injection site reactions | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Fever after injection | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Worsening of RA | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |