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 @ 1:30 PM
Ignite Modification Date: 2025-12-25 @ 12:32 PM
NCT ID: NCT01097395
Description: None
Frequency Threshold: 5
Time Frame: 48 Weeks
Study: NCT01097395
Study Brief: Concentration-Controlled Ribavirin for the Treatment of Patients With Chronic Hepatitis C Virus Infection
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard Weight-Based Ribavirin Dosing 1000 mg daily in patients weighing \<75 kg and 1200 mg daily in patients weighing ≥ 75 kg ribavirin: Randomization to standard weight based ribavirin dosing (1000 or 1200 mg daily) or concentration-guided dosing based on first dose AUC0-12 0 None 4 17 14 17 View
Concentration-Controlled Ribavirin Dosing Dose adjusted based on first dose AUC0-12 ribavirin: Randomization to standard weight based ribavirin dosing (1000 or 1200 mg daily) or concentration-guided dosing based on first dose AUC0-12 0 None 7 18 12 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemoglobin < 8.5 g/dL NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Frozen arms NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tooth pain and vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Astrocytoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Shortness of breath NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Mood alteration NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hemoglobin < 10 g/dL NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
ANC < 1000/mm3 NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Platelets < 75,000/mm3 NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
WBC <2000/mm3 NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Grade 3 Depression NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Grade 3 Fatigue NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Grade 3 Insomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Grade 3 Mood Alteration NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Grade 3 Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Grade 3 Shortness of Breath NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View