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 @ 9:32 PM
Ignite Modification Date: 2025-12-25 @ 7:16 PM
NCT ID: NCT00260832
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00260832
Study Brief: Trial of Decitabine in Patients With Acute Myeloid 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
Cytarabine or Supportive Care Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.) None None 162 237 231 237 View
Dacogen (Decitabine) Only 20 mg/m\^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks. None None 190 238 237 238 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia None Infections and infestations None View
Sepsis None Infections and infestations None View
Septic Shock None Infections and infestations None View
Bronchopneumonia None Infections and infestations None View
Febrile Neutropenia None Blood and lymphatic system disorders None View
Thrombocytopenia None Blood and lymphatic system disorders None View
Anemia None Blood and lymphatic system disorders None View
Neutropenia None Blood and lymphatic system disorders None View
Disease Progression None General disorders None View
Pyrexia None General disorders None View
General Physical Health Deterioration None General disorders None View
Atrial Fibrillation None Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pyrexia None General disorders None View
Disease Progression None General disorders None View
Peripheral Edema None General disorders None View
Pneumonia None Infections and infestations None View
Urinary Tract Infection None Infections and infestations None View
Oral Herpes None Infections and infestations None View
Thrombocytopenia None Blood and lymphatic system disorders None View
Anemia None Blood and lymphatic system disorders None View
Febrile Neutropenia None Blood and lymphatic system disorders None View