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 @ 2:31 PM
Ignite Modification Date:
2025-12-25 @ 1:04 PM
NCT ID:
NCT01060059
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT01060059
Study Brief:
Exenatide and Basal Insulins Use in the Real Setting: an Observational Study 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 |
|---|---|---|---|---|---|---|---|---|
| Exenatide | The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day | None | None | 11 | 444 | 19 | 444 | View |
| Basal Insulin | The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment | None | None | 10 | 438 | 9 | 438 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Iron deficiency anaemia | None | Blood and lymphatic system disorders | None | View |
| Atrial fibrillation | None | Cardiac disorders | None | View |
| Cardiac failure | None | Cardiac disorders | None | View |
| Coronary artery disease | None | Cardiac disorders | None | View |
| Ischaemic cardiomyopathy | None | Cardiac disorders | None | View |
| Myocardial infarction | None | Cardiac disorders | None | View |
| Vertigo positional | None | Ear and labyrinth disorders | None | View |
| Duodenal ulcer | None | Gastrointestinal disorders | None | View |
| Pancreatitis haemorrhagic | None | Gastrointestinal disorders | None | View |
| Cholelithiasis | None | Hepatobiliary disorders | None | View |
| Carbon monoxide poisoning | None | Injury, poisoning and procedural complications | None | View |
| Metabolic disorder | None | Metabolism and nutrition disorders | None | View |
| Breast cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Myelodysplastic syndrome | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Neoplasm malignant | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Carotid artery stenosis | None | Nervous system disorders | None | View |
| Cerebrovascular accident | None | Nervous system disorders | None | View |
| Cerebrovascular insufficiency | None | Nervous system disorders | None | View |
| Coma hepatic | None | Nervous system disorders | None | View |
| Urinary tract inflammation | None | Renal and urinary disorders | None | View |
| Benign prostatic hyperplasia | None | Reproductive system and breast disorders | None | View |
| Acute respiratory failure | None | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diabetic retinopathy | None | Eye disorders | None | View |
| Diarrhoea | None | Gastrointestinal disorders | None | View |
| Dyspepsia | None | Gastrointestinal disorders | None | View |
| Pancreatitis | None | Gastrointestinal disorders | None | View |
| Chest pain | None | General disorders | None | View |
| Bronchitis | None | Infections and infestations | None | View |
| Herpes zoster | None | Infections and infestations | None | View |
| Lung infection | None | Infections and infestations | None | View |
| Hand fracture | None | Injury, poisoning and procedural complications | None | View |
| Gamma-glutamyltransferase increased | None | Investigations | None | View |
| Lipase increased | None | Investigations | None | View |
| Dehydration | None | Metabolism and nutrition disorders | None | View |
| Hyperamylasaemia | None | Metabolism and nutrition disorders | None | View |
| Hyperglycaemia | None | Metabolism and nutrition disorders | None | View |
| Hyperkalaemia | None | Metabolism and nutrition disorders | None | View |
| Hyperlipasaemia | None | Metabolism and nutrition disorders | None | View |
| Muscle spasms | None | Musculoskeletal and connective tissue disorders | None | View |
| Osteoarthritis | None | Musculoskeletal and connective tissue disorders | None | View |
| Pain in extremity | None | Musculoskeletal and connective tissue disorders | None | View |
| Carotid artery stenosis | None | Nervous system disorders | None | View |
| Headache | None | Nervous system disorders | None | View |
| Haematuria | None | Renal and urinary disorders | None | View |
| Vocal cord polyp | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Skin exfoliation | None | Skin and subcutaneous tissue disorders | None | View |
| Skin ulcer | None | Skin and subcutaneous tissue disorders | None | View |
| Hospitalisation | None | Surgical and medical procedures | None | View |