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 @ 9:56 PM
Ignite Modification Date: 2025-12-25 @ 7:34 PM
NCT ID: NCT00422032
Description: None
Frequency Threshold: 5
Time Frame: 4 years, 10 months.
Study: NCT00422032
Study Brief: 2 Arm Study of Clofarabine IV in MDS Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
15 mg/m^2 Clofarabine Lower Dose Clofarabine Group A: 15 mg/m\^2 intravenous (IV) over 1 hour daily for 5 days None None 7 37 35 37 View
30 mg/m^2 Clofarabine Higher Dose Clofarabine Group B: 30 mg/m\^2 IV over 1 hour daily for 5 days None None 8 21 20 21 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
Hemorhage SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Death SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Thrombosis SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Skin Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Transaminase elevations SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Elevated Creatinine SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Myalgia/bone pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Edema SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Acute Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Weakness SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Prolonged Myelosuppression SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View