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 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT00968812
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.
MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
Frequency Threshold:
5
Time Frame:
Adverse event data were collected for the duration of the study (104 weeks).
Study:
NCT00968812
Study Brief:
CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
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 100 mg: Baseline to Week 52 | Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52. | None | None | 24 | 483 | 138 | 483 | View |
| Canagliflozin 300 mg: Baseline to Week 52 | Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52. | None | None | 26 | 485 | 150 | 485 | View |
| Glimepiride: Baseline to Week 52 | Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52. | None | None | 39 | 482 | 175 | 482 | View |
| Canagliflozin 100 mg: Baseline to Week 104 | Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104. | None | None | 47 | 483 | 198 | 483 | View |
| Canagliflozin 300 mg: Baseline to Week 104 | Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104. | None | None | 47 | 485 | 204 | 485 | View |
| Glimepiride: Baseline to Week 104 | Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104. | None | None | 69 | 482 | 242 | 482 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEDDRA 14.1 / 15.0 | View |
| Acute coronary syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 / 15.0 | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 / 15.0 | View |
| Angina unstable | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 / 15.0 | View |
| Aortic valve incompetence | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 / 15.0 | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 / 15.0 | View |
| Bundle branch block left | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 / 15.0 | View |
| Cardiac arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 / 15.0 | View |
| Cardiomyopathy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 / 15.0 | View |
| Coronary artery disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 / 15.0 | View |
| Diabetic cardiomyopathy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 / 15.0 | View |
| Mitral valve incompetence | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 / 15.0 | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 / 15.0 | View |
| Myocardial ischaemia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 / 15.0 | View |
| Pericardial effusion | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 / 15.0 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 / 15.0 | View |
| Ventricular arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 / 15.0 | View |
| Angle closure glaucoma | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 14.1 / 15.0 | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 14.1 / 15.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 14.1 / 15.0 | View |
| Duodenal ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 14.1 / 15.0 | View |
| Duodenitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 14.1 / 15.0 | View |
| Inguinal hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 14.1 / 15.0 | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 14.1 / 15.0 | View |
| Small intestinal perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 14.1 / 15.0 | View |
| Umbilical hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 14.1 / 15.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 14.1 / 15.0 | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 14.1 / 15.0 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 14.1 / 15.0 | View |
| Cholecystitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEDDRA 14.1 / 15.0 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEDDRA 14.1 / 15.0 | View |
| Hepatic cyst | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEDDRA 14.1 / 15.0 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Endometritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Localised infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Lobar pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Lung infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Postoperative wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Respiratory tract infection viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Staphylococcal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Eye injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Femoral neck fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Foot fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Incisional hernia | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Ligament sprain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Lower limb fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Meniscus lesion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Muscle injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Muscle rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Road traffic accident | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Skull fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Subdural haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Toxicity to various agents | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Ulna fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Wrist fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 14.1 / 15.0 | View |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 / 15.0 | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 / 15.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 / 15.0 | View |
| Spinal column stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 / 15.0 | View |
| Endometrial cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 / 15.0 | View |
| Renal cancer stage I | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 / 15.0 | View |
| Squamous cell carcinoma of the cervix | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 / 15.0 | View |
| Uterine leiomyoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 / 15.0 | View |
| Carotid arterial embolus | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 14.1 / 15.0 | View |
| Cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 14.1 / 15.0 | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 14.1 / 15.0 | View |
| Hemiplegic migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 14.1 / 15.0 | View |
| Vertebrobasilar insufficiency | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 14.1 / 15.0 | View |
| Confusional state | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 14.1 / 15.0 | View |
| Stress | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 14.1 / 15.0 | View |
| Incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEDDRA 14.1 / 15.0 | View |
| Dysfunctional uterine bleeding | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MEDDRA 14.1 / 15.0 | View |
| Menstrual disorder | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MEDDRA 14.1 / 15.0 | View |
| Allergic bronchitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 / 15.0 | View |
| Chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 / 15.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 / 15.0 | View |
| Interstitial lung disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 / 15.0 | View |
| Pulmonary oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 / 15.0 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 14.1 / 15.0 | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA 14.1 / 15.0 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA 14.1 / 15.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA 14.1 / 15.0 | View |
| Hypertensive crisis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA 14.1 | View |
| Intermittent claudication | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA 14.1 / 15.0 | View |
| Acute myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 / 15.0 | View |
| Cardiac failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 / 15.0 | View |
| Coronary artery occlusion | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 14.1 / 15.0 | View |
| Arnold-Chiari malformation | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MEDDRA 14.1 / 15.0 | View |
| Philmosis | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MEDDRA 14.1 / 15.0 | View |
| Diabetic retinopathy | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 14.1 / 15.0 | View |
| Vitreous haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 14.1 / 15.0 | View |
| Abdominal strangulated herina | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 14.1 / 15.0 | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 14.1 / 15.0 | View |
| Pancreatitis acute | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 14.1 / 15.0 | View |
| Pancreatitis chronic | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 14.1 / 15.0 | View |
| Cyst | NON_SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 14.1 / 15.0 | View |
| Cholecystitis chronic | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEDDRA 14.1 / 15.0 | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Orchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Chemical poisoning | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Clavicle fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Concussion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Femur fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Head injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Heat exhaustion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Humerus fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Joint dislocation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Procedural complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Procedural nausea | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 14.1 / 15.0 | View |
| Electrocardiogram T wave biphasic | NON_SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 14.1 / 15.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 14.1 / 15.0 | View |
| Diabetes mellitus inadequate control | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 14.1 / 15.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 14.1 / 15.0 | View |
| Obesity | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 14.1 / 15.0 | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 / 15.0 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 / 15.0 | View |
| Polyarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 / 15.0 | View |
| Breast cancer stage I | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 / 15.0 | View |
| Colon cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 / 15.0 | View |
| Gastrointestinal tract adenoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 / 15.0 | View |
| Hepatic neoplasm | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 / 15.0 | View |
| Lung neoplasm | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 / 15.0 | View |
| Oesophageal carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 / 15.0 | View |
| Prostate cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 / 15.0 | View |
| Complex regional pain syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 14.1 / 15.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 14.1 / 15.0 | View |
| Haemorrhage intracranial | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 14.1 / 15.0 | View |
| Hemiparesis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 14.1 / 15.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 14.1 / 15.0 | View |
| Transient ischaemic attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 14.1 / 15.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 14.1 / 15.0 | View |
| Calculus ureteric | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEDDRA 14.1 / 15.0 | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEDDRA 14.1 / 15.0 | View |
| Renal failure acute | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEDDRA 14.1 / 15.0 | View |
| Urethral stenosis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEDDRA 14.1 / 15.0 | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEDDRA 14.1 / 15.0 | View |
| Benign prostatic hyperplasia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MEDDRA 14.1 / 15.0 | View |
| Prostatitis | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MEDDRA 14.1 / 15.0 | View |
| Prostatomegaly | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MEDDRA 14.1 / 15.0 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 / 15.0 | View |
| Diabetic foot | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 14.1 / 15.0 | View |
| Familial risk factor | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | MEDDRA 14.1 / 15.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA 14.1 / 15.0 | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Small bowel perforation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MEDDRA 14.1 / 15.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 14.1 / 15.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 14.1 / 15.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 14.1 / 15.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 / 15.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 14.1 / 15.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA 14.1 / 15.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 14.1 / 15.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 / 15.0 | View |