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: 2025-12-24 @ 2:55 PM
Ignite Modification Date: 2025-12-25 @ 1:20 PM
NCT ID: NCT03305159
Description: The survey of vaginal \& urinary symptoms used in this study was designed using the PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) created by the NIH \& NCI 7. The language \& format of the PTO-CTCAE questions have been cognitively tested. Questions on vaginal burning and itching were investigator-developed items using similar language as the PRO-CTCAE, since these adverse events were not contained in the PRO-CTCAE item library.
Frequency Threshold: 0
Time Frame: Data were collected for each patient immediately postoperatively to 24-48 hours postoperatively.
Study: NCT03305159
Study Brief: Tolerance of Chlorhexidine Gluconate Vaginal Cleansing Solution
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control (Povidone Iodine) Patients to receive povidone iodine for the surgical preparation of the vagina. Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina. 0 None 0 63 0 63 View
Intervention (4% Chlorhexidine Gluconate) Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina. 4% Chlorhexidine Gluconate: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina. 0 None 0 60 1 59 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Severe Swelling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View