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 @ 5:39 PM
Ignite Modification Date:
2025-12-25 @ 3:09 PM
NCT ID:
NCT02512068
Description:
Reported data were number of participants who occurred at least one AEs for each arm and not for each intervention (Placebo versus Trelagliptin 25 mg) because collection of data for each intervention were not planned at the start of this study. Total number of participants at risk for each arm were defined as the participants who occurred at least one dose of trelagliptin 25 mg tablet under Safety Analysis Set defined as all participants who received at least one dose of the study drug.
Frequency Threshold:
5
Time Frame:
Up to Week 54
Study:
NCT02512068
Study Brief:
A Phase 3, Randomized, Double-blind, Parallel-group, Comparative Study and a Phase 3, Multicenter, Open-label, Long-term Study of SYR-472 (25 mg) in Patients With Type 2 Diabetes Mellitus Complicated by Severe Renal Impairment or End-stage Renal Disease
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Trelagliptin 25 mg | Trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period I + II) | 0 | None | 23 | 55 | 48 | 55 | View |
| Placebo and Trelagliptin 25 mg | Placebo tablet, orally, once weekly before breakfast for up to Week 12 (Period I), followed by trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period II) | 0 | None | 16 | 48 | 39 | 48 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA/J Ver. 21.0 | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA/J Ver. 21.0 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA/J Ver. 21.0 | View |
| Atrioventricular block complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA/J Ver. 21.0 | View |
| Coronary artery occlusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA/J Ver. 21.0 | View |
| Coronary artery stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA/J Ver. 21.0 | View |
| Sudden hearing loss | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA/J Ver. 21.0 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA/J Ver. 21.0 | View |
| Diabetic retinopathy | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA/J Ver. 21.0 | View |
| Gastrointestinal necrosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J Ver. 21.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J Ver. 21.0 | View |
| Large intestine polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J Ver. 21.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J Ver. 21.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA/J Ver. 21.0 | View |
| Vascular stent stenosis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA/J Ver. 21.0 | View |
| Cholangitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA/J Ver. 21.0 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA/J Ver. 21.0 | View |
| Anaphylactic shock | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA/J Ver. 21.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J Ver. 21.0 | View |
| Cholangitis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J Ver. 21.0 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J Ver. 21.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J Ver. 21.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J Ver. 21.0 | View |
| Shunt occlusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J Ver. 21.0 | View |
| Shunt stenosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J Ver. 21.0 | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J Ver. 21.0 | View |
| Shunt malfunction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J Ver. 21.0 | View |
| Vascular access malfunction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J Ver. 21.0 | View |
| Fluid overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA/J Ver. 21.0 | View |
| Lumbar spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J Ver. 21.0 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J Ver. 21.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J Ver. 21.0 | View |
| Colon adenoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J Ver. 21.0 | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J Ver. 21.0 | View |
| Loss of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J Ver. 21.0 | View |
| Dementia with Lewy bodies | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J Ver. 21.0 | View |
| Myelopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J Ver. 21.0 | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA/J Ver. 21.0 | View |
| Diabetic nephropathy | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA/J Ver. 21.0 | View |
| Sleep apnoea syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA/J Ver. 21.0 | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J Ver. 21.0 | View |
| Peripheral arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA/J Ver. 21.0 | View |
| Subclavian vein stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA/J Ver. 21.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J Ver. 21.0 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J Ver. 21.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J Ver. 21.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J Ver. 21.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J Ver. 21.0 | View |
| Procedural hypotension | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J Ver. 21.0 | View |
| Shunt stenosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J Ver. 21.0 | View |
| Skin abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J Ver. 21.0 | View |
| Blood pressure decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J Ver. 21.0 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA/J Ver. 21.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA/J Ver. 21.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J Ver. 21.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J Ver. 21.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J Ver. 21.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J Ver. 21.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA/J Ver. 21.0 | View |
| Upper respiratory tract inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA/J Ver. 21.0 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J Ver. 21.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA/J Ver. 21.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J Ver. 21.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J Ver. 21.0 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J Ver. 21.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J Ver. 21.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J Ver. 21.0 | View |