Adverse Events Module

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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

Ignite Creation Date: 2025-12-25 @ 2:16 AM
Ignite Modification Date: 2025-12-26 @ 12:46 AM
NCT ID: NCT04859660
Description: Participation in this study involves minimal risk
Frequency Threshold: 0
Time Frame: 8 weeks
Study: NCT04859660
Study Brief: Pre-operative Tamsulosin and Time to Spontaneous Void After Hysterectomy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Group Placebo arm: Participants will be given Placebo the pre-op bay. 0 None 1 80 3 80 View
Tamsulosin- Intervention Group Tamsulosin arm: Participants will be given Tamsulosin in the pre-op bay 0 None 2 81 4 81 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospital admission SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vaginal cuff dehiscence SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pelvic abscess SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Kidney stone SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
vaginal bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View