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 |
|---|---|---|---|---|---|---|---|---|
| Vaginal Estrogen Therapy Group | Women randomized to vaginal estrogen therapy were offered vaginal cream conjugated estrogen (Premarin) 0.5 gm per vaginal twice weekly or estradiol (Estrace): 1gm per vaginal twice weekly Conjugated estrogen: Current standard treatment for recurrent UTIs in postmenopausal women Estradiol: Current standard treatment for recurrent UTIs in postmenopausal women | 0 | None | 2 | 7 | 3 | 7 | View |
| Laser Therapy Group | Women randomized to the laser therapy group underwent 3 treatments, 6 weeks apart. Mona Lisa Touch: Fractional CO2 LASER | 0 | None | 0 | 5 | 3 | 5 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Thrombophlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Vaginal irritation | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Abnormal bleeding | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Increase vaginal discharge | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Vaginal burning | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Vaginal itching | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |