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 @ 12:40 PM
Ignite Modification Date: 2025-12-25 @ 12:12 PM
NCT ID: NCT00960661
Description: As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
Frequency Threshold: 1.5
Time Frame: None
Study: NCT00960661
Study Brief: A Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects 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
Insulin Lispro (BBT) Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) None None 26 312 175 312 View
Exenatide (BET) Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) None None 23 315 228 315 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia None Blood and lymphatic system disorders None View
Angina unstable None Cardiac disorders None View
Cardiac failure congestive None Cardiac disorders None View
Coronary artery disease None Cardiac disorders None View
Acute myocardial infarction None Cardiac disorders None View
Angina pectoris None Cardiac disorders None View
Cardiac failure None Cardiac disorders None View
Myocardial ischaemia None Cardiac disorders None View
Vitreous haemorrhage None Eye disorders None View
Diabetic retinopathy None Eye disorders None View
Cataract None Eye disorders None View
Glaucoma None Eye disorders None View
Abdominal pain None Gastrointestinal disorders None View
Gastrooesophageal reflux disease None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Cholecystitis acute None Hepatobiliary disorders None View
Cholecystitis chronic None Hepatobiliary disorders None View
Osteomyelitis None Infections and infestations None View
Pyelonephritis None Infections and infestations None View
Urinary tract infection None Infections and infestations None View
Bacterial infection None Infections and infestations None View
Escherichia urinary tract infection None Infections and infestations None View
Pneumonia None Infections and infestations None View
Post procedural infection None Infections and infestations None View
Pyelonephritis acute None Infections and infestations None View
Ankle fracture None Injury, poisoning and procedural complications None View
Fall None Injury, poisoning and procedural complications None View
Lower limb fracture None Injury, poisoning and procedural complications None View
Meniscus lesion None Injury, poisoning and procedural complications None View
Ureteroscopy None Investigations None View
Musculoskeletal chest pain None Musculoskeletal and connective tissue disorders None View
Exostosis None Musculoskeletal and connective tissue disorders None View
Osteoarthritis None Musculoskeletal and connective tissue disorders None View
Rotator cuff syndrome None Musculoskeletal and connective tissue disorders None View
Pancreatic carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Rectal cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Uterine leiomyoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Carotid artery thrombosis None Nervous system disorders None View
Encephalopathy None Nervous system disorders None View
Haemorrhagic stroke None Nervous system disorders None View
Ischaemic stroke None Nervous system disorders None View
Cerebral haemorrhage None Nervous system disorders None View
Hypoglycaemic coma None Nervous system disorders None View
Calculus ureteric None Renal and urinary disorders None View
Calculus urinary None Renal and urinary disorders None View
Renal failure acute None Renal and urinary disorders None View
Nephrolithiasis None Renal and urinary disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Diabetic foot None Skin and subcutaneous tissue disorders None View
Arterial bypass operation None Surgical and medical procedures None View
Percutaneous coronary intervention None Surgical and medical procedures None View
Hypertensive crisis None Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea None Gastrointestinal disorders None View
Dyspepsia None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Bronchitis None Infections and infestations None View
Influenza None Infections and infestations None View
Nasopharyngitis None Infections and infestations None View
Headache None Nervous system disorders None View
Back Pain None Musculoskeletal and connective tissue disorders None View
Decreased appetite None Metabolism and nutrition disorders None View
Abdominal pain None Gastrointestinal disorders None View
Urinary tract infection None Infections and infestations None View
Dizziness None Nervous system disorders None View
Pharyngitis None Infections and infestations None View
Gastroenteritis None Infections and infestations None View
Constipation None Gastrointestinal disorders None View
Gastritis None Gastrointestinal disorders None View
Abdominal pain upper None Gastrointestinal disorders None View
pain in extremity None General disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
seasonal allergy None Immune system disorders None View
arthralgia None Musculoskeletal and connective tissue disorders None View
musculoskeletal pain None Musculoskeletal and connective tissue disorders None View
upper respiratory tract infection None Infections and infestations None View
tooth infection None Infections and infestations None View
hypertension None Vascular disorders None View
Osteoarthritis None Musculoskeletal and connective tissue disorders None View
anxiety None Psychiatric disorders None View
toothache None Gastrointestinal disorders None View
anemia None Blood and lymphatic system disorders None View