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 @ 5:03 PM
Ignite Modification Date: 2025-12-25 @ 2:42 PM
NCT ID: NCT01604850
Description: None
Frequency Threshold: 5
Time Frame: Baseline to posttreatment Week 24 plus 30 days
Study: NCT01604850
Study Brief: Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)
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+Placebo Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks. Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets. None None 5 103 92 103 View
SOF+RBV Participants were randomized to receive sofosbuvir+RBV for 16 weeks. Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. None None 3 98 86 98 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Oesophageal varices haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Portal vein thrombosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 15.0 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 15.0 View
Hepatic neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 15.0 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 15.0 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 15.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 15.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 15.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 15.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 15.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 15.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.0 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 15.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 15.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 15.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 15.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 15.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 15.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 15.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 15.0 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 15.0 View