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 @ 3:10 AM
Ignite Modification Date: 2025-12-26 @ 1:48 AM
NCT ID: NCT02030405
Description: None
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT02030405
Study Brief: Ixazomib (MLN9708) in Treating Patients With Relapsed or Refractory 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
Ixazomib (MLN9708) Participants receive ixazomib (orally) PO on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 4 None 4 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile Neutropenia NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
AML Disease progression NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Pancytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dehydration NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Acute Respiratory Distress Syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Cardiopulmonary Arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Rectal Pain NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Acute Pulmonary Edema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Skin Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View