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: 2025-12-26 @ 12:14 PM
Ignite Modification Date: 2025-12-26 @ 12:14 PM
NCT ID: NCT00382200
Description: None
Frequency Threshold: 0
Time Frame: up to 1 year
Study: NCT00382200
Study Brief: Decitabine and Tretinoin in Treating Patients With 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
Phase I: Tretinoin 45 mg/m2/Day Decitabine and All-Trans Retonoic Acid (Tretinoin) 0 None 5 5 5 5 View
Phase I: Tretinoin 65 mg/m2/Day Decitabine and All-Trans Retonoic Acid (Tretinoin) 2 None 9 14 14 14 View
Phase I: Tretinoin 85 mg/m2/Day Decitabine and All-Trans Retonoic Acid (Tretinoin) 1 None 5 7 7 7 View
Phase II: MTD Tretinoin 65 mg/m2/Day Decitabine and All-Trans Retonoic Acid (Tretinoin) 10 None 21 28 28 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain/cramping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bilirubin SYSTEMATIC_ASSESSMENT Investigations None View
Blood, bone marrow, other SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cardiovascular, Arrhythmia, other SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiovascular, other SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Creatinine SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Derm, skin other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Edema SYSTEMATIC_ASSESSMENT General disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal, other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infection without neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection with febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutrophils SYSTEMATIC_ASSESSMENT Investigations None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Typhlitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Wound, infectious SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Creatinine SYSTEMATIC_ASSESSMENT Investigations None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infection with grade 3/4 neutr SYSTEMATIC_ASSESSMENT Infections and infestations None View
Derm, skin other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Infection w/out neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Hypermagnemesia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
PTT SYSTEMATIC_ASSESSMENT Investigations None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
PT SYSTEMATIC_ASSESSMENT Investigations None View
Amylase SYSTEMATIC_ASSESSMENT Investigations None View
Lipase SYSTEMATIC_ASSESSMENT Investigations None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blood bicarbonate SYSTEMATIC_ASSESSMENT Investigations None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotention SYSTEMATIC_ASSESSMENT Vascular disorders None View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Typhlitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GI, other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fibrinogen SYSTEMATIC_ASSESSMENT Investigations None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Investigations None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Investigations None View
Pulmonary, other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Platelets SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophils SYSTEMATIC_ASSESSMENT Investigations None View
Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Leukocytes SYSTEMATIC_ASSESSMENT Investigations None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
ALT SYSTEMATIC_ASSESSMENT Investigations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
AST SYSTEMATIC_ASSESSMENT Investigations None View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Alkaline Phosphatase SYSTEMATIC_ASSESSMENT Investigations None View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations None View
Bilirubin SYSTEMATIC_ASSESSMENT Investigations None View
Rash, desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View