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: 2025-12-26 @ 10:56 AM
Ignite Modification Date: 2025-12-26 @ 10:56 AM
NCT ID: NCT02766608
Description: Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Frequency Threshold: 2
Time Frame: Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug
Study: NCT02766608
Study Brief: Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BFF MDI 320/9.6 μg Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg 3 None 42 655 240 655 View
BFF MDI 160/9.6 μg Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg 2 None 45 637 201 637 View
FF MDI 9.6 μg Formoterol Fumarate Metered Dose Inhalation 9.6 μg 2 None 72 644 219 644 View
BD MDI 320 μg Budesonide Metered Dose Inhalation 320 μg 0 None 15 206 75 206 View
Symbicort TBH 400/12 μg Symbicort Turbuhaler 400/12 μg 2 None 20 219 57 219 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure chronic SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Arteriosclerosis coronary artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Congestive cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Abdominal hernia gangrenous SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Breast abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Embolic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Intracranial aneurysm SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRa View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Colitis ischaemic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRa View
Diverticulum intestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hiatus hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Inflammatory bowel disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Strangulated umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Acetabulum fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Dural tear SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Forearm fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Vascular pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Brain cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Breast cancer male SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Bronchial carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Gastric neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Mesothelioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Metastases to liver SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Metastatic carcinoma of the bladder SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Non-small cell lung cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Pancreatic carcinoma metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Arteriosclerosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertensive emergency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Peripheral artery thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Thrombophlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Incarcerated hernia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Sudden cardiac death SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cachexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Diabetes with hyperosmolarity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Hypertonic bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal tubular necrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Device battery issue SYSTEMATIC_ASSESSMENT Product Issues MedDRA View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Prostatic haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Skull fractured base SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Renal cyst SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders medDRA View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View