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 @ 5:56 PM
Ignite Modification Date:
2025-12-25 @ 3:20 PM
NCT ID:
NCT01191268
Description:
None
Frequency Threshold:
3
Time Frame:
None
Study:
NCT01191268
Study Brief:
A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 1.5 mg LY2189265 | LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks | None | None | 27 | 295 | 219 | 295 | View |
| 0.75 mg LY2189265 | LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks | None | None | 46 | 293 | 232 | 293 | View |
| Insulin Glargine | Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks | None | None | 53 | 296 | 203 | 296 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Generalized edema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Multi-organ failure | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Multiple organ failure | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Acute cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.0 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.0 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.0 | View |
| Acute sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Cellulitis of foot | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Cellulitis of leg | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Epiglottitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Gangrenous appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Hypoglycemic episode | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Cervical pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Costochondritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Lumbar pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Muscle atrophy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Viith nerve paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Major depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Mental confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Psychosis | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Psychotic disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Calculus ureteric | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Hypertensive emergency | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.0 | View |
| Haemorrhagic anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.0 | View |
| Hemorrhagic anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.0 | View |
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.0 | View |
| Iron deficiency anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.0 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Arteriosclerosis coronary artery | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Atrioventricular block complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Atrioventricular block third degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Cardiac pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Cardiogenic shock | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Chest pain - cardiac | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Congestive heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Coronary artery insufficiency | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Coronary atherosclerosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Coronary insufficiency | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Decompensated heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Fibrillation ventricular | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Heart block third degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Infarct myocardial | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Non st segment elevation myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Non stemi | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Non-sustained ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Unstable angina | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Ventricular fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Retinal detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Retinal haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Retinal hemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Abdominal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Abdominal herniation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Chronic diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Colonic polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Gastroenteritis noninfectious | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Gastrointestinal bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Gastrointestinal inflammation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Haemorrhoidal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Hemorrhoidal bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Ileus paralytic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Lower gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Lower gastrointestinal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Paralytic ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Chest pain exertional | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Ancylostomiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Gastroenteritis norovirus | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Hookworm infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Infected bites | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Infected toe | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Localised infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Pleurisy viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Staphylococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Staphylococcus aureus septicemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Supraglottitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Urinary infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Back injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Falling | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Fractured ribs | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Fractured sternum | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Knee fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Leg injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Lower limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Lumbar vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Lumbar vertebral fracture l1 | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Meniscus lesion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Meniscus tear | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Muscle rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Quadriceps tendon rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Sternal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Suture related complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Tendon rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Torn muscle | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Osteoarthritis aggravated | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Rotator cuff syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Rotator cuff tear | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Gallbladder adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Gallbladder cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Non-small cell lung cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Rectal adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Rectal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Rectal neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Amyotrophic lateral sclerosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Carotid artery disease | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Carpal tunnel syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Cerebellar infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Haemorrhagic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Hemorrhagic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Hydrocephalus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Hypoglycaemic coma | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Hypoglycemic coma | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Ischemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Lumboischialgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Metabolic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Orthostatic collapse | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Palsy bells | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Transient cerebral ischemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Unilateral carpal tunnel syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Pyuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Renal artery stenosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Renal stone | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Unilateral renal artery stenosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Ureteral calculus | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Ureteric calculus | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Erectile dysfunction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 15.0 | View |
| Menorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 15.0 | View |
| Premenopausal menorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 15.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Shortness of breath | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Arteriosclerosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.0 | View |
| Atherosclerosis generalized | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.0 | View |
| Bleeding | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.0 | View |
| Haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Heartburn | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Common cold | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Flu syndrome | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Dyslipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Dyslipidemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Shoulder pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.0 | View |