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 @ 4:29 AM
Ignite Modification Date: 2025-12-26 @ 3:32 AM
NCT ID: NCT02121418
Description: Other \[not including serious\] adverse events were not addressed.
Frequency Threshold: 0
Time Frame: 2 years
Study: NCT02121418
Study Brief: Decitabine and Cytarabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia, High Risk Myelodysplastic Syndrome, or Myeloproliferative Neoplasm
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 (Decitabine, Cytarabine) Patients receive decitabine IV daily on days 1-10 and cytarabine IV QD on days 1-7. Treatment repeats every 28-35 days for 2 courses in the absence of disease progression or unacceptable toxicity. After course 3, patients achieving remission will receive 1-2 more courses of therapy at the same dose. Patients in remission with significant side effects will receive decitabine and cytarabine at decreased doses. Patients not achieving remission will not receive any more treatment. 12 patients were consented and treated. 9 None 11 12 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
MRSA Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hyponatremia SYSTEMATIC_ASSESSMENT Investigations None View
Hypertension SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Staph Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypokalemia SYSTEMATIC_ASSESSMENT Investigations None View
Right cheek cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bacterial Liver Abscess SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Muscle Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
C. Difficile Diarrhea SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Pyomyositis of B/L calf SYSTEMATIC_ASSESSMENT Infections and infestations None View
Afibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Investigations None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Esophagogastric mucosal junction ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Clostridium Ramosum bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rothia Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral mucositis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):