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 @ 6:36 PM
Ignite Modification Date: 2025-12-25 @ 4:06 PM
NCT ID: NCT01201057
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01201057
Study Brief: Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
0.5% SPL7013 Gel 0.5% SPL7013 Gel: Vaginal gel None None 0 32 6 32 View
1.0% SPL7013 Gel 1.0% SPL7013 Gel: Vaginal gel None None 0 32 4 32 View
3.0% SPL7013 Gel 3.0% SPL7013 Gel: Vaginal gel None None 0 29 5 29 View
Placebo Gel Placebo Gel: Vaginal gel None None 0 32 4 32 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vulvovaginal pruritus None Reproductive system and breast disorders None View
Vulvovaginal burning sensation None Reproductive system and breast disorders None View
Vulvovaginal candidiasis None Infections and infestations None View
Metrorrhagia None Reproductive system and breast disorders None View