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 |
|---|---|---|---|---|---|---|---|---|
| GLASSIA Infusion Rate- 0.04 mL/kg/Min | Participants who received simultaneous infusions of: - GLASSIA at 0.04 mL/kg/min - Placebo at 0.2 mL/kg/min | None | None | 0 | 30 | 8 | 30 | View |
| GLASSIA Infusion Rate- 0.2 mL/kg/Min | Participants who received simultaneous infusions of: - GLASSIA at 0.2 mL/kg/min - Placebo at 0.04 mL/kg/min | None | None | 0 | 30 | 4 | 30 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pain In Extremity | None | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Headache | None | Nervous system disorders | MedDRA (Unspecified) | View |
| Dizziness | None | Nervous system disorders | MedDRA (Unspecified) | View |
| Back Pain | None | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |