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 @ 4:58 AM
Ignite Modification Date: 2025-12-26 @ 3:59 AM
NCT ID: NCT04532918
Description: None
Frequency Threshold: 0
Time Frame: From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
Study: NCT04532918
Study Brief: Pharmacokinetics of Verinurad and Allopurinol in Combination With Cyclosporine and Rifampicin in Healthy Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Period 3: Verinurad + Allopurinol + Rifampicin Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5. 0 None 1 13 2 13 View
Period 1: Verinurad + Allopurinol Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5. 0 None 0 14 2 14 View
Period 2: Verinurad + Allopurinol + Cyclosporine Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5. 0 None 0 14 10 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bone contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0. View
Clavicle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0. View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0. View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0. View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0. View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0. View
Feeling hot NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0. View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0. View
Vessel puncture site haematoma NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0. View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0. View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0. View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0. View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0. View
Head discomfort NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0. View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0. View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0. View
Chromaturia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0. View