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 @ 7:13 PM
Ignite Modification Date: 2025-12-25 @ 4:49 PM
NCT ID: NCT03063203
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
Study: NCT03063203
Study Brief: Single Agent Decitabine in TP53 Mutated Relapsed/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
Decitabine * Cycle 1: All patients will receive decitabine 20 mg/m\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle * Cycle 2: Patients with bone marrow blast counts \< 5% may receive decitabine 20 mg/m\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. * Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle 15 None 4 17 17 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bacteremia streptococcus SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Facial cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Oily skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Traumatic fat necrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Rash maculopapular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Knots SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Localized edema - right breast SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Infusion related reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Cellulitis on shin SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Staphylococcus epidermis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Thrush SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Cardiac troponin I increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hip pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Shoulder pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (4.0) View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastrointestinal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Chest tightness SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Chest pain - cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View