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 @ 2:53 PM
Ignite Modification Date: 2025-12-25 @ 1:19 PM
NCT ID: NCT00267059
Description: None
Frequency Threshold: 5
Time Frame: 3 years
Study: NCT00267059
Study Brief: Lenalidomide (Revlimid) in Chronic Lymphocytic Leukemia (CLL)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lenalidomide 10 mg/day, orally once a day for 28 days None None 24 44 34 44 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pseudomonas Aeruginosa Bactremia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Death SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Pneumocystis carinii pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Mucormycosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Fever of unknown origin SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Rotavirus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Tumor Flare SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Secondary Malignancy Lung SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (3.0) View
Viral Hepatitis Reactivation SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (3.0) View
Prostate Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Stroke SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Criptosporididosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Tumor Flare SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View