Adverse Events Module

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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 @ 12:16 PM
Ignite Modification Date: 2025-12-26 @ 12:16 PM
NCT ID: NCT01887600
Description: The safety emergent period was defined as the evaluation period from analysis date of first drug intake up to 28 days after the analysis last dose. All-cause mortality was monitored at any time after first administration of study drug to the end of the post-study follow-up, which includes deaths reported after the 28-day follow-up after the last dose of study drug.
Frequency Threshold: 5
Time Frame: From first dose of study drug up to 28 days after the last dose of study drug (up to 108 weeks), and up to 2.836 years at maximum for all-cause mortality
Study: NCT01887600
Study Brief: Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Roxadustat Participants received roxadustat according to the tiered weight-based approach, with starting doses of 70 mg given thrice weekly (TIW) to participants weighing up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received roxadustat for at least 52 weeks up to a maximum of 104 weeks. 45 None 241 391 204 391 View
Placebo Participants received matching placebo according to the tiered weight-based approach, with starting doses of 70 mg given thrice weekly (TIW) to participants weighing up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received matching placebo for at least 52 weeks up to a maximum of 104 weeks. 20 None 115 203 103 203 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20 View
Haemorrhagic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20 View
Heparin-induced thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20 View
Lymphadenopathy mediastinal SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20 View
Nephrogenic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Acute left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Arteriosclerosis coronary artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Cardiac failure chronic SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Congenital cystic kidney disease SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 20 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 20 View
Goitre SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 20 View
Hyperparathyroidism primary SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 20 View
Hyperparathyroidism secondary SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 20 View
Macular hole SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20 View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20 View
Ulcerative keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Diabetic gastroparesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Gastric ulcer perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Gastritis erosive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Haemorrhagic erosive gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Large intestinal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Pancreatitis chronic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Catheter site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Sudden cardiac death SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Hepatic mass SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20 View
Steatohepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20 View
Allergy to arthropod bite SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 20 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Appendicitis perforated SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Bronchitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Bursitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Diabetic foot infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Enterobacter bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Epididymitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Hepatic echinococciasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Hepatitis B SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Infected skin ulcer SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Meningoencephalitis herpetic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Orchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Pneumonia staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Pulmonary sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Pyelonephritis chronic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Pyonephrosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Urinary tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Vulvovaginitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Arterial injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Arteriovenous fistula site complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Arteriovenous fistula thrombosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Craniocerebral injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Facial bones fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Fat embolism SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Postoperative wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Pubis fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20 View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20 View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Diabetes mellitus inadequate control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Diabetic metabolic decompensation SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Hypervolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Gouty arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20 View
Joint contracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20 View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20 View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20 View
Adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Bladder transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Lipoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Metastases to the mediastinum SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Metastatic carcinoma of the bladder SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Myelodysplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Dementia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Diabetic neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Hypertensive encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Hypoglycaemic coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Myasthenic syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Partial seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Vascular encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Device dislocation SYSTEMATIC_ASSESSMENT Product Issues MedDRA 20 View
Device malfunction SYSTEMATIC_ASSESSMENT Product Issues MedDRA 20 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20 View
Disorientation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Acute prerenal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Azotaemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Calculus bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
End stage renal disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Oliguria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Urethral stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20 View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20 View
Ovarian cyst torsion SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Hydrothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20 View
Diabetic foot SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20 View
Eczema nummular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20 View
Panniculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20 View
Toxic skin eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20 View
Hospitalisation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 20 View
Leg amputation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 20 View
Aortic stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Blood pressure inadequately controlled SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Diabetic vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Extremity necrosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Peripheral artery stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Peripheral vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Iron deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View