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 @ 10:48 PM
Ignite Modification Date: 2025-12-25 @ 8:17 PM
NCT ID: NCT04594369
Description: The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
Frequency Threshold: 5
Time Frame: Up to Week 56
Study: NCT04594369
Study Brief: A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Brensocatib 10 mg Participants received brensocatib 10 mg tablets, orally, once daily, for 52 weeks. 2 None 101 582 197 582 View
Brensocatib 25 mg Participants received brensocatib 25 mg tablets, orally, once daily, for 52 weeks. 4 None 97 574 213 574 View
Placebo Participants received a brensocatib matching placebo tablets orally, once daily, for 52 weeks. 8 None 108 563 203 563 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 27.0 View
Atrioventricular block SYSTEMATIC_ASSESSMENT Cardiac disorders 27.0 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders 27.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders 27.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders 27.0 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders 27.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders 27.0 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders 27.0 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders 27.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders 27.0 View
Diastolic dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders 27.0 View
Ischaemic cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders 27.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders 27.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders 27.0 View
Blindness transient SYSTEMATIC_ASSESSMENT Eye disorders 27.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders 27.0 View
Cataract nuclear SYSTEMATIC_ASSESSMENT Eye disorders 27.0 View
Vitreoretinal traction syndrome SYSTEMATIC_ASSESSMENT Eye disorders 27.0 View
Vitreous haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders 27.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 27.0 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 27.0 View
Femoral hernia incarcerated SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 27.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 27.0 View
Malabsorption SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 27.0 View
Mechanical ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 27.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders 27.0 View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders 27.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders 27.0 View
Biliary cyst SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 27.0 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 27.0 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 27.0 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 27.0 View
Hepatic steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 27.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders 27.0 View
Aspergillus infection SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Bronchitis fungal SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Burkholderia gladioli infection SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Coronavirus infection SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Gastroenteritis cryptosporidial SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Klebsiella infection SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Large intestine infection SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Lung abscess SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Mastitis SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Periorbital cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Pneumonia influenzal SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Pneumonia necrotising SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Pneumonia pneumococcal SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Pneumonia pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Pyelonephritis chronic SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Viral pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Alcohol poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.0 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.0 View
Cervical vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.0 View
Clavicle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.0 View
Fibula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.0 View
Foreign body in throat SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.0 View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.0 View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.0 View
Patella fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.0 View
Pelvic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.0 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.0 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.0 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.0 View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 27.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 27.0 View
Arthropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 27.0 View
Intervertebral disc disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 27.0 View
Joint range of motion decreased SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 27.0 View
Mobility decreased SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 27.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 27.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 27.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 27.0 View
Polymyalgia rheumatica SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 27.0 View
Spondylolisthesis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 27.0 View
Synovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 27.0 View
Anal squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 27.0 View
Benign salivary gland neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 27.0 View
Brain neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 27.0 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 27.0 View
Colorectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 27.0 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 27.0 View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 27.0 View
Malignant melanoma in situ SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 27.0 View
Mantle cell lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 27.0 View
Papillary thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 27.0 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 27.0 View
Transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 27.0 View
Uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 27.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders 27.0 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders 27.0 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders 27.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders 27.0 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders 27.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders 27.0 View
Device dislocation SYSTEMATIC_ASSESSMENT Product Issues 27.0 View
Device malfunction SYSTEMATIC_ASSESSMENT Product Issues 27.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders 27.0 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders 27.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders 27.0 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders 27.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders 27.0 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 27.0 View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 27.0 View
Pelvic organ prolapse SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 27.0 View
Uterovaginal prolapse SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 27.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 27.0 View
Bronchiectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 27.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 27.0 View
Eosinophilic pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 27.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 27.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 27.0 View
Lung opacity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 27.0 View
Nasal polyps SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 27.0 View
Pneumothorax spontaneous SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 27.0 View
Pulmonary arterial hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 27.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 27.0 View
Actinic keratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 27.0 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 27.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 27.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders 27.0 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders 27.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders 27.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders 27.0 View
Aortic valve stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders 27.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders 27.0 View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders 27.0 View
Macular hole SYSTEMATIC_ASSESSMENT Eye disorders 27.0 View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders 27.0 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 27.0 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 27.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 27.0 View
Abscess neck SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Empyema SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Endophthalmitis SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Scrub typhus SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Limb traumatic amputation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.0 View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.0 View
Meniscus injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 27.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 27.0 View
Urinary sediment abnormal SYSTEMATIC_ASSESSMENT Investigations 27.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations 27.0 View
Pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 27.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 27.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 27.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 27.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 27.0 View