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 @ 7:17 PM
Ignite Modification Date: 2025-12-25 @ 4:55 PM
NCT ID: NCT00525603
Description: None
Frequency Threshold: 5
Time Frame: 5 years 7 months
Study: NCT00525603
Study Brief: CFAR Study in Patients With Chronic Lymphocytic Leukemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CFAR Participants received fludarabine 20 mg/m\^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m\^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m\^2 IV on day 2 for C1 and 500mg/m\^2 IV on day 2 for C2-6. None None 11 60 52 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Elevated Creatinine SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Drug Reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Mucositis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Pain Other SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Infection Other SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View