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 @ 1:19 AM
Ignite Modification Date: 2025-12-25 @ 11:28 PM
NCT ID: NCT01896193
Description: Safety Analysis Set
Frequency Threshold: 5
Time Frame: Up to 24 weeks plus 30 days
Study: NCT01896193
Study Brief: Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SOF+RBV 16 Weeks SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks None None 1 62 16 62 View
SOF+RBV 24 Weeks SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks None None 1 65 21 65 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 16.1 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 16.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 16.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 16.1 View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 16.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 16.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 16.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 16.1 View