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 @ 5:00 PM
Ignite Modification Date: 2025-12-25 @ 2:41 PM
NCT ID: NCT02993250
Description: Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].
Frequency Threshold: 5
Time Frame: Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)
Study: NCT02993250
Study Brief: A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis Participants received AL-335 800 mg (2\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks. 0 None 1 11 9 11 View
Cohort 1: Chronic Hepatitis C Without Cirrhosis Participants received AL-335 800 milligram (mg) (2\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks. 0 None 0 22 15 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrioventricular Block First Degree NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 20.0 View
Supraventricular Extrasystoles NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 20.0 View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 20.0 View
Eye Discharge NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 20.0 View
Abdominal Pain Upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 20.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 20.0 View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 20.0 View
Gastrointestinal Motility Disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 20.0 View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 20.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 20.0 View
Oral Herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 20.0 View
Viral Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 20.0 View
Alanine Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 20.0 View
Aspartate Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 20.0 View
Blood Cholesterol Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 20.0 View
Neck Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 20.0 View
Pain in Extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 20.0 View
Tenosynovitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 20.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 20.0 View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 20.0 View