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 @ 3:44 AM
Ignite Modification Date: 2025-12-26 @ 2:30 AM
NCT ID: NCT02449902
Description: Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
Frequency Threshold: 0
Time Frame: Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Study: NCT02449902
Study Brief: TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and 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
TX-12-004-HR Active treatment group. None None 0 24 13 24 View
Placebo Control treatment group. None None 0 26 4 26 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye Contusion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.0 View
Vaginal dysplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 16.0 View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 16.0 View
Vulvovaginal discomfort SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 16.0 View
Vulvovaginal burning sensation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 16.0 View
Vulvovaginal pruritus SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 16.0 View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 16.0 View
Vulvovaginal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 16.0 View
Hot flush SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 16.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.0 View