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 @ 2:11 AM
Ignite Modification Date: 2025-12-26 @ 12:39 AM
NCT ID: NCT04214860
Description: None
Frequency Threshold: 5
Time Frame: 18 months
Study: NCT04214860
Study Brief: APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1 APR-246 4.5 g/day APR-246: APR-246 4.5 g/day Venetoclax: Venetoclax 400 mg once daily 6 None 5 6 6 6 View
Cohort 2 APR-246 4.5 g/day APR-246: APR-246 4.5 g/day Venetoclax: Venetoclax 400 mg once daily Azacitidine: Subcutaneous injection, or intravenous infusion 26 None 32 43 43 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
abdominal abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fungal Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infusion Site Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Periorbital Celluitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic Shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis Fungal Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Parotitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory Syncytial Virus Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hemorrahge intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cytokine release syndorme SYSTEMATIC_ASSESSMENT Immune system disorders None View
Acute Myeloid Leukemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Acute Febrile Neutrophilic Deramotsis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Inguinal Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Obstruction Gastric SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal Hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper Gastrointestinal Hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Disease progression SYSTEMATIC_ASSESSMENT General disorders None View
Mucosal Inflammation SYSTEMATIC_ASSESSMENT General disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Gait Disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycaridia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute Respiratory distress Syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Mass SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Failure to Thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Tumor Lysis Syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkelaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Confusional State SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Subdural Harmatoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin Increased SYSTEMATIC_ASSESSMENT Investigations None View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasuea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Decreased Appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Edema Peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatgiue SYSTEMATIC_ASSESSMENT General disorders None View
White Blood Cell Count Deceased SYSTEMATIC_ASSESSMENT Investigations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
chills SYSTEMATIC_ASSESSMENT General disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Confusional State SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sinus Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
contusion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperphospataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Abdominal Distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gait Disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT General disorders None View
Asthenia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View