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 @ 9:36 PM
Ignite Modification Date: 2025-12-25 @ 7:20 PM
NCT ID: NCT01831232
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01831232
Study Brief: Idarubicin, Cytarabine, and Pravastatin Sodium in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. pravastatin sodium: Given PO idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies 6 None 2 24 24 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Multi organ failure secondary to sepsis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Febrile neutropenia Grade 3 NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Febrile neutropenia Grade 4 NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Rash Grade 3 NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hand-foot syndrome Grade 3 NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Septic shock (Grade 4) NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diarrhea Grade 3 NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea/Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Transaminitis Grade 3 NON_SYSTEMATIC_ASSESSMENT Investigations None View
Colon pneumatosis Grade 3 NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GI bleeding Grade 3 NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tumor lysis syndrome Grade 3 NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View