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 @ 5:32 PM
Ignite Modification Date: 2025-12-25 @ 3:05 PM
NCT ID: NCT02448368
Description: Overall number of baseline participants used to determine number of participants at risk.
Frequency Threshold: 0
Time Frame: None
Study: NCT02448368
Study Brief: RDEA3170 Tablet and Capsule Bioavailability Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment A Verinurad capsules, 5 mg (FN24), administered in the fasted state. None None 0 20 1 20 View
Treatment B Verinurad capsules, 5 mg (FN24), administered in the fed state (highfat, high-calorie meal). None None 0 20 1 20 View
Treatment C Verinurad capsules, 10 mg (FN25), administered in the fasted state. None None 0 20 0 20 View
Treatment D RDEA3170 capsules, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal) None None 0 20 0 20 View
Treatment E RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state. None None 0 20 0 20 View
Treatment I Verinurad capsules, 10 mg (FN26), administered in the fasted state. None None 0 15 2 15 View
Treatment J Verinurad capsules, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal). None None 0 15 2 15 View
Treatment K Verinurad tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state. None None 0 15 0 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Musculoskeletal Stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View