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 @ 12:44 AM
Ignite Modification Date: 2025-12-25 @ 10:57 PM
NCT ID: NCT03151967
Description: None
Frequency Threshold: 5
Time Frame: 18 weeks
Study: NCT03151967
Study Brief: Lactobacillus Probiotic for Prevention of UTI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Applicator With LACTIN-V Treatment Vaginal applicator containing Lactobacillus crispatus CTV-05 Lactobacillus crispatus CTV-05: vaginal applicator with medium containing drug 0 None 0 14 14 14 View
Applicator With Placebo Inactive vaginal applicator without any drug Placebo: vaginal applicator with medium containing no drug 0 None 0 13 13 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye disorders SYSTEMATIC_ASSESSMENT Eye disorders None View
Blood and lymphatic system disorders SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Gastrointestinal disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infections and Infestations SYSTEMATIC_ASSESSMENT Infections and infestations None View
Musculoskeletal and connective tissue disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nervous system disorders SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Renal and urinary disorders SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Reproductive system and breast disorders SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Skin and subcutaneous tissue disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View