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 @ 7:50 PM
Ignite Modification Date: 2025-12-25 @ 5:26 PM
NCT ID: NCT02104804
Description: Total numbers at risk indicate the number of participants in the Safety Analysis set. Out of 466 randomized, 1 did not take study drug.
Frequency Threshold: 0
Time Frame: None
Study: NCT02104804
Study Brief: Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin Combined With Metformin in Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SAXAGLIPTIN 5 MG QD + INSULIN WITH OR WITHOUT METFORMIN None None None 12 234 89 234 View
PLACEBO QD + INSULIN WITH OR WITHOUT METFORMIN None None None 14 231 96 231 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Deafness neurosensory SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Vitreous haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Hepatitis E SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urethritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Diabetes mellitus inadequate control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Ankylosing spondylitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Gastric cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Gastrointestinal carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Basal ganglia haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Cerebral ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Lacunar infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Calculus ureteric SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Arteriosclerosis coronary artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 18.1 View
Asthenopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Diabetic retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Chronic gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Dysbacteriosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Periodontal disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Hepatic steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Conjunctivitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Helicobacter infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Hepatitis E SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Periodontitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Foreign body SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Ligament injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Ulna fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Creatinine renal clearance decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Eosinophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypochloraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Limb discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Periarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Cerebrovascular insufficiency SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Diabetic neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Diabetic nephropathy SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Sexual dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Diabetic vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View