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 @ 5:43 PM
Ignite Modification Date: 2025-12-25 @ 3:11 PM
NCT ID: NCT01011868
Description: None
Frequency Threshold: 5
Time Frame: During the course of the study (82 weeks)
Study: NCT01011868
Study Brief: Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Empagliflozin 10 mg Empagliflozin 10 mg orally once daily None None 28 169 110 169 View
Empagliflozin 25 mg Empagliflozin 25 mg orally once daily None None 28 155 95 155 View
Placebo Oral Placebo None None 28 170 115 170 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.0 View
Scrotal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.0 View
Thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA 15.0 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA 15.0 View
Bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA 15.0 View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA 15.0 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA 15.0 View
Gastric cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA 15.0 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA 15.0 View
Malignant fibrous histiocytoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA 15.0 View
Mycosis fungoides SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA 15.0 View
Pancreatic carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA 15.0 View
Prostatic adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA 15.0 View
Squamous cell carcinoma of the cervix SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA 15.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA 15.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA 15.0 View
Hypovolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA 15.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MEDDRA 15.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 15.0 View
Carotid artery occlusion SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 15.0 View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 15.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 15.0 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 15.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 15.0 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 15.0 View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 15.0 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 15.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 15.0 View
Macular fibrosis SYSTEMATIC_ASSESSMENT Eye disorders MEDDRA 15.0 View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MEDDRA 15.0 View
Vitreous haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MEDDRA 15.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MEDDRA 15.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 15.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 15.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 15.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 15.0 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 15.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 15.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 15.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 15.0 View
Coronary artery occlusion SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 15.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 15.0 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 15.0 View
Right ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 15.0 View
Femoral arterial stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA 15.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA 15.0 View
Peripheral vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA 15.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA 15.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA 15.0 View
Vocal cord polyp SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA 15.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.0 View
Enterocutaneous fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.0 View
Gastric ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.0 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.0 View
Oesophageal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.0 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.0 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.0 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.0 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDDRA 15.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 15.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 15.0 View
Costochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 15.0 View
Joint contracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 15.0 View
Joint instability SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 15.0 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 15.0 View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 15.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA 15.0 View
Nephrotic syndrome SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA 15.0 View
Neurogenic bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA 15.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA 15.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA 15.0 View
Arnold-Chiari malformation SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MEDDRA 15.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MEDDRA 15.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MEDDRA 15.0 View
Device failure SYSTEMATIC_ASSESSMENT General disorders MEDDRA 15.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MEDDRA 15.0 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MEDDRA 15.0 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.0 View
Accident at home SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.0 View
Accident at work SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.0 View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.0 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.0 View
Limb crushing injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.0 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.0 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.0 View
Skeletal injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.0 View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.0 View
Carotid endarterectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MEDDRA 15.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.0 View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA 15.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MEDDRA 15.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 15.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA 15.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA 15.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 15.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MEDDRA 15.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 15.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 15.0 View