Adverse Events Module

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 @ 7:58 PM
Ignite Modification Date: 2025-12-25 @ 5:32 PM
NCT ID: NCT03151304
Description: None
Frequency Threshold: 5
Time Frame: All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
Study: NCT03151304
Study Brief: A Safety and Efficacy Study of Pracinostat and Azacitidine in Patients With High Risk 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
Stage 1a and 1b Open-label Pracinostat Plus Azacitidine open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles. In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression. Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules: * Schedule 1 - daily therapy on Days 1 through 7 * Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle Pracinostat: 45 mg capsule Azacitidine: SC or IV injection 5 None 45 64 64 64 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Streptococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Vascular access site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Anal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Proctitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Rectal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Clostridial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Escherichia sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Fungal oesophagitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Perirectal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Pseudomonal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Sialoadenitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Electrocardiogram qt prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hyperinsulinaemic hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Mania SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Mental disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 20.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Tongue discolouration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
International normalised ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Papule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View