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 @ 3:27 AM
Ignite Modification Date: 2025-12-26 @ 2:08 AM
NCT ID: NCT00493805
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00493805
Study Brief: Study of Response in Chronic Hepatitis C (CHC) Participants Genotype 1 With Insulin Resistance and Prolonged Treatment Duration in Late Responders (P04823/MK-4031-303)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Non Interventional Arm HOMA IR <=2 None None None 3 17 15 17 View
Interventional Arm HOMA IR >2 None None None 4 42 37 42 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
CORONARY ARTERY DISEASE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
HYPERTHYROIDISM SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 12.1 View
NON-CARDIAC CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
SUICIDE ATTEMPT SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
HAEMOGLOBINAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
LEUKOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
HYPOTHYROIDISM SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 12.1 View
VISUAL ACUITY REDUCED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.1 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
CHAPPED LIPS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
CHEILITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
DRY MOUTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
GINGIVAL BLEEDING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
ORAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
FEELING COLD SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
DYSGEUSIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
HYPOTONIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
DYSTHYMIC DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
SLEEP DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
ASTHMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
DRY THROAT SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
ALOPECIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
DRY SKIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
ERYTHEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
NEURODERMATITIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
URTICARIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
POOR PERIPHERAL CIRCULATION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View