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 @ 1:20 PM
Ignite Modification Date: 2025-12-25 @ 12:26 PM
NCT ID: NCT04266795
Description: At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
Frequency Threshold: 5
Time Frame: From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
Study: NCT04266795
Study Brief: A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2 Venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m\^2 IV or SC dosing on Days 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022. 15 None 55 80 79 80 View
Pevonedistat 20 mg/m^2 + Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2 Pevonedistat 20 mg/m\^2 as a 60-minute IV infusion on Days 1, 3, and 5 in each 28-day cycle plus venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m\^2 IV or SC dosing on Day 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022. 18 None 62 81 79 81 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Acinetobacter bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24 View
Acute myeloid leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24 View
Acute myeloid leukaemia recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Altered state of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Arthritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Bronchitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Bronchopulmonary aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Capillary leak syndrome SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Catheter site cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Condition aggravated SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Cryptococcosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Deafness neurosensory SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Device related sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Enterobacter bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Enterococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Escherichia sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Febrile bone marrow aplasia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24 View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24 View
Hyperleukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24 View
Hypotensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Intervertebral disc disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24 View
Intervertebral discitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Myelosuppression SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Neutropenic sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Pneumonia fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Pneumonia legionella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Portal vein cavernous transformation SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24 View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Prostate cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24 View
Respiratory acidosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Respiratory syncytial virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Soft tissue inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Systemic candida SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Toxic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Tumour lysis syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Escherichia bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24 View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Tumour lysis syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View