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:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
NCT ID:
NCT02284893
Description:
Including Data After Rescue, Treated Subjects
Frequency Threshold:
2
Time Frame:
52 weeks
Study:
NCT02284893
Study Brief:
Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| SAXA + DAPA + MET | Saxagliptin 5-mg tablet+Dapagliflozin 10-mg tablet+Placebo capsules matching the sitagliptin 100-mg capsules+Metformin background therapy | 0 | None | 9 | 232 | 112 | 232 | View |
| Sita + Met | Placebo tablet matching the saxagliptin 5-mg tablet+Placebo tablet matching the dapagliflozin 10-mg tablet+Sitagliptin 100-mg capsules+Metformin background therapy | 0 | None | 13 | 229 | 123 | 229 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| CORONARY ARTERY DISEASE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDRA 19.1 | View |
| PALPITATIONS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDRA 19.1 | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDRA 19.1 | View |
| CARDIAC FAILURE CHRONIC | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDRA 19.1 | View |
| CARDIAC FAILURE CONGESTIVE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDRA 19.1 | View |
| CONGESTIVE CARDIOMYOPATHY | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDRA 19.1 | View |
| MITRAL VALVE PROLAPSE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDRA 19.1 | View |
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDRA 19.1 | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDRA 19.1 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDRA 19.1 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDRA 19.1 | View |
| ANAL FISSURE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDRA 19.1 | View |
| ADENOCARCINOMA OF COLON | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDRA 19.1 | View |
| MENINGIOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDRA 19.1 | View |
| POST LAMINECTOMY SYNDROME | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDRA 19.1 | View |
| LACERATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDRA 19.1 | View |
| LOWER LIMB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDRA 19.1 | View |
| UPPER LIMB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDRA 19.1 | View |
| DYSFUNCTIONAL UTERINE BLEEDING | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MEDRA 19.1 | View |
| ENDOMETRIOSIS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MEDRA 19.1 | View |
| LUMBAR RADICULOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDRA 19.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDRA 19.1 | View |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDRA 19.1 | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDRA 19.1 | View |
| MENTAL STATUS CHANGES | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDRA 19.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDRA 19.1 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDRA 19.1 | View |
| OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDRA 19.1 | View |
| ACUTE RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDRA 19.1 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDRA 19.1 | View |
| DRUG HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MEDRA 19.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDRA 19.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDRA 19.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEDRA 19.1 | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDRA 19.1 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDRA 19.1 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDRA 19.1 | View |
| DYSLIPIDAEMIA | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MEDRA 19.1 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDRA 19.1 | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDRA 19.1 | View |
| VULVOVAGINAL MYCOTIC INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDRA 19.1 | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDRA 19.1 | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDRA 19.1 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDRA 19.1 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDRA 19.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDRA 19.1 | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEDRA 19.1 | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDRA 19.1 | View |
| GASTRITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDRA 19.1 | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MEDRA 19.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDRA 19.1 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDRA 19.1 | View |