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 @ 4:56 PM
Ignite Modification Date: 2025-12-25 @ 2:38 PM
NCT ID: NCT02237950
Description: Safety population was all patients in the Intent-to-Treat population, but excluding those who later returned all the study medication unused.
Frequency Threshold: 5
Time Frame: None
Study: NCT02237950
Study Brief: Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence 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
1% SPL7013 Gel Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days 1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks. None None 4 294 92 294 View
Placebo Gel Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks None None 3 291 80 291 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tachycardia None Cardiac disorders None View
Bartholin's abscess None Infections and infestations None View
Klebsiella bacteremia None Infections and infestations None View
Hemiplegic migraine None Nervous system disorders None View
Blighted ovum None Pregnancy, puerperium and perinatal conditions None View
Suicidal ideation None Psychiatric disorders None View
Menorrhagia None Reproductive system and breast disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis None Infections and infestations None View
UTI None Infections and infestations None View
Vulvovaginal candidiasis None Infections and infestations None View
Vulvovaginal mycotic infection None Infections and infestations None View
Headache None Nervous system disorders None View