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 @ 2:43 AM
Ignite Modification Date: 2025-12-26 @ 1:22 AM
NCT ID: NCT02308033
Description: Adverse events were collected through direct questioning at each post-baseline visit, by participant diaries, and by spontaneous reporting. The safety population includes all participants randomized to treatment and administered at least one dose of study drug, and includes subjects who had a normal gram stain Nugent score at the baseline visit.
Frequency Threshold: 5
Time Frame: Adverse events were collected over the entire course of the study (up to 30 days after beginning treatment).
Study: NCT02308033
Study Brief: Multi-Center Study of New Medications to Treat Vaginal Infections
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Metronidazole Vaginal Gel One applicator full at bedtime Metronidazole 0 None 0 96 25 96 View
Gel Vehicle One applicator full at bedtime Gel vehicle 0 None 0 97 10 97 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vulvovaginal pruritis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (18.1) View
Vulvovaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Vulvovaginal mycotic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.1) View