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 @ 5:12 PM
Ignite Modification Date: 2025-12-25 @ 2:50 PM
NCT ID: NCT04103450
Description: SAEs and TEAEs were collected in Safety analysis set.
Frequency Threshold: 5
Time Frame: Up to Week 52
Study: NCT04103450
Study Brief: Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
52-Week Vibegron Group Participants in Study URO-901-3005 who had been randomized to receive vibegron 75 mg once daily, orally will continue to receive same treatment in Study URO-901-3006, for an additional 28 weeks. Thus, participants will receive total 52 weeks of 75 mg vibegron treatment. No dosage adjustments were allowed. 0 None 2 142 17 142 View
28-Week Vibegron Group Participants in Study URO-901-3005 who had been randomized to receive the placebo will receive study treatment of vibegron 75 mg once daily, orally for 28 weeks during the open label extension period. No dosage adjustments were allowed. 0 None 3 134 3 134 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (25.0) View
Cervical vertebral fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (25.0) View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (25.0) View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (25.0) View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (25.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (25.0) View
Hypertension NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (25.0) View