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 @ 2:34 PM
Ignite Modification Date: 2025-12-25 @ 1:06 PM
NCT ID: NCT02304159
Description: None
Frequency Threshold: 5
Time Frame: From start of treatment to 12 weeks after stopping treatment.
Study: NCT02304159
Study Brief: Study to Evaluate the Safety and Efficacy of Daclatasvir/Sofosbuvir/Ribavirin for 16 Versus 24 Weeks for HCV Genotype 3 Cirrhotics
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group A - 16 Weeks of Treatment Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 16 weeks daclatasvir, Daklinza Sofosbuvir, Sovaldi Ribavirin 1 None 0 21 21 21 View
Group A - 24 Weeks of Treatment Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 24 weeks daclatasvir, Daklinza Sofosbuvir, Sovaldi Ribavirin 1 None 2 18 18 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Violence NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Flu-like symptoms NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Decreased Appetite NON_SYSTEMATIC_ASSESSMENT General disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Mood Changes NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Decompensation NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View