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: 2026-03-26 @ 3:21 PM
Ignite Modification Date: 2026-03-26 @ 3:21 PM
NCT ID: NCT00305227
Description: Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.
Frequency Threshold: 0.5
Time Frame: 10 weeks for serious adverse events
Study: NCT00305227
Study Brief: Intravaginal LACTIN-V for Prevention of Recurrent Urinary Tract Infection
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lactin-V Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks. None None 0 50 28 50 View
Placebo Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks. None None 0 50 25 50 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Painful urination SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pain in lower abdomen SYSTEMATIC_ASSESSMENT General disorders None View
Low back pain SYSTEMATIC_ASSESSMENT General disorders None View
Other urinary symptoms SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vaginal odor SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Abnormal vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal itch SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Painful intercourse SYSTEMATIC_ASSESSMENT General disorders None View
Redness/irritation of genitals SYSTEMATIC_ASSESSMENT General disorders None View
Genital swelling SYSTEMATIC_ASSESSMENT General disorders None View
Other vaginal symptoms SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Other symptoms SYSTEMATIC_ASSESSMENT General disorders None View