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 @ 2:05 AM
Ignite Modification Date: 2025-12-26 @ 12:30 AM
NCT ID: NCT01358760
Description: None
Frequency Threshold: 5
Time Frame: From Baseline to Week 12 (+ 30-day follow-up period after last dose)
Study: NCT01358760
Study Brief: Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks. None None 5 150 19 150 View
0.25% DHEA DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks. None None 1 143 17 143 View
0.50% DHEA DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks. None None 1 148 23 148 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastritis erosive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Movement disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Stress SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View