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 @ 6:56 PM
Ignite Modification Date: 2025-12-25 @ 4:29 PM
NCT ID: NCT01687257
Description: Adverse event data includes all participants who were randomized to the study.
Frequency Threshold: 5
Time Frame: Up to 48 weeks plus 30 days
Study: NCT01687257
Study Brief: Sofosbuvir and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation
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 (Group 1) SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks None None 4 25 23 25 View
Observation Period Only (Group 2) This reporting group includes participants who were randomized to the Observation/SOF+RBV group and received up to 24 weeks of observation. None None 3 25 10 25 View
SOF+RBV Treatment Only (Group 2) This reporting group includes participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks. None None 6 21 20 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Eye swelling SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Oesophageal varices haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Hepatic cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Drug abuse SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Restless legs syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View