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 |
|---|---|---|---|---|---|---|---|---|
| Arthritis Treatment | Participants received one of three treatments: * Botulism Toxin Type A: One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule * Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine * Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution 8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group. | 0 | None | 0 | 8 | 0 | 8 | View |