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 @ 4:48 PM
Ignite Modification Date: 2025-12-25 @ 2:34 PM
NCT ID: NCT01446250
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01446250
Study Brief: Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Alisporivir Adverse event (AE) occurred while taking Alisporivir + PEGinf + RBV. None None 0 5 5 5 View
Boceprevir AE occurred while taking Boceprevir + PEGinf + RBV. None None 1 8 8 8 View
PEGinf + RBV AE occurred while taking only PEGinf + RBV. None None 0 8 4 8 View
No Intervention AE was discovered while taking no intervention. None None 0 6 1 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pruritus Generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Rash Pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.0 View
Influenza Like Illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.0 View
Disturbance in Attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Vision Blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Haematocrit Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Haemoglobin Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Chest Discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Gastric Ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Gastroenteritis Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Sleep Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0 View
Libido Decreased SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0 View
Hot Flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Pharyngitis Streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Seasonal Allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 16.0 View
Ageusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Oral Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Blood Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Confusional State SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0 View
Memory Impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View