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 @ 2:29 AM
Ignite Modification Date: 2025-12-26 @ 1:04 AM
NCT ID: NCT04550234
Description: None
Frequency Threshold: 0
Time Frame: From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
Study: NCT04550234
Study Brief: A Study in Healthy Subjects to Assess Drug Availability of 4 Different Formulations of Verinurad and Allopurinol
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 1 Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1 0 None 0 25 8 25 View
Treatment 2 Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1 0 None 0 25 2 25 View
Treatment 3 Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1 0 None 0 25 2 25 View
Treatment 4 Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1 0 None 0 25 6 25 View
Treatment 5 Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1 0 None 0 25 2 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 24.0 View
Head discomfort NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 24.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 24.0 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 24.0 View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.0 View
Swelling of eyelid NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 24.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.0 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.0 View
Lip blister NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.0 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 24.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 24.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 24.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 24.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.0 View
Feeling hot NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.0 View
Arthropod bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 24.0 View