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:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT01137812
Description:
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
Frequency Threshold:
5
Time Frame:
Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
Study:
NCT01137812
Study Brief:
The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Canagliflozin 300 mg | Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea. | None | None | 24 | 377 | 157 | 377 | View |
| Sitagliptin 100 mg | Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea. | None | None | 21 | 378 | 159 | 378 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina unstable | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 | View |
| Arteriosclerosis coronary artery | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 | View |
| Cardiac arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 | View |
| Coronary artery disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 | View |
| Ischaemic cardiomyopathy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 14.1 | View |
| Small intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 14.1 | View |
| Bile duct obstruction | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEDDRA 14.1 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEDDRA 14.1 | View |
| Gallbladder oedema | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEDDRA 14.1 | View |
| Bronchopneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 | View |
| Leptospirosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 | View |
| Pneumonia bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 | View |
| Pyelonephritis chronic | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 | View |
| Arthropod bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 | View |
| Hand fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 | View |
| Hip fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 | View |
| Incisional hernia, obstructive | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 | View |
| Lower limb fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 | View |
| Meniscus lesion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 | View |
| Splenic rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 | View |
| Tendon rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 | View |
| Toxicity to various agents | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 | View |
| Wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 | View |
| Obesity | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 14.1 | View |
| Lumbar spinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | View |
| Cervix carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 | View |
| Lung neoplasm malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 | View |
| Oropharyngeal cancer stage unspecified | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 | View |
| Uterine leiomyoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 14.1 | View |
| Cervical cord compression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 14.1 | View |
| Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 14.1 | View |
| Transient ischaemic attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 14.1 | View |
| Suicide attempt | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 14.1 | View |
| Renal colic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEDDRA 14.1 | View |
| Vaginal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MEDDRA 14.1 | View |
| Respiratory arrest | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | View |
| Leukocytoclastic vasculitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | View |
| Arterial thrombosis limb | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA 14.1 | View |
| Arteriosclerosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA 14.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 14.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 14.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 14.1 | View |