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: 2025-12-25 @ 12:32 AM
Ignite Modification Date: 2025-12-25 @ 10:39 PM
NCT ID: NCT03335267
Description: None
Frequency Threshold: 0
Time Frame: 2.5 Years
Study: NCT03335267
Study Brief: Investigator Initiated Trial of CPX-351 for Untreated 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
CPX-351 (Cytarabine:Daunorubicin) Injection Dosing for first induction: CPX-351 • CPX-351 at 100u/m2 will be administered on study days 1, 3 and 5 Dosing for second induction: • CPX-351 at 100 u/m2 will be administered on days 1 and 3 Dosing for consolidation: • CPX-351 at 65 u/m2 will be administered on days 1 and 3 CPX-351: Cytarabine:Daunorubicin Liposome Injection 23 None 14 30 30 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenic fever SYSTEMATIC_ASSESSMENT General disorders None View
Hemorrhagic cerebrovascular accident SYSTEMATIC_ASSESSMENT Vascular disorders None View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Volume overload SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Massive hemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Failure to thrive SYSTEMATIC_ASSESSMENT General disorders None View
Cardiopulmonary arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypotensive episode SYSTEMATIC_ASSESSMENT Vascular disorders None View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutropenic fever SYSTEMATIC_ASSESSMENT General disorders None View
Transient episodes of pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Streptococcus bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Severe diffuse cerebral dysfunction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
UTI (klebsiella pneumonia) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anorexia with malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Investigations None View
Hypokalemia SYSTEMATIC_ASSESSMENT Investigations None View
Purple macules SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Elevated ALT SYSTEMATIC_ASSESSMENT Investigations None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Investigations None View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Investigations None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Transaminitis SYSTEMATIC_ASSESSMENT Investigations None View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Typhlitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
VRE bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Decreased LVEF SYSTEMATIC_ASSESSMENT Cardiac disorders None View
GI adenovirus SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
C. difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View