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: 2025-12-25 @ 4:54 AM
Ignite Modification Date: 2025-12-26 @ 3:54 AM
NCT ID: NCT02021318
Description: Total number of deaths (all causes) includes deaths reported after the time frame above. The safety emergent period was defined as the evaluation period from the analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
Frequency Threshold: 4.95
Time Frame: From first dose of study drug up to end of study (up to week 108)
Study: NCT02021318
Study Brief: Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa
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 orally according to the tiered weight-based approach, with starting dose of 70 mg given TIW to participants weighing between 45 kg up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg up to 160 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 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 up to a maximum of 104 weeks. 40 None 209 323 223 323 View
Darbepoetin Alfa Participants received initial dose of darbepoetin alfa based upon the weight \[either 0.45 μg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 μg/kg of body weight, as a single subcutaneous injection once every 2 weeks\] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment 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 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 darbepoetin alfa 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 darbepoetin alfa for up to a maximum of 104 weeks. 37 None 181 293 203 293 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
Hypocoagulable state SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20 View
Immune thrombocytopenic purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20 View
Iron deficiency anaemia 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 myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Angina pectoris 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
Atrioventricular block second degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Bradycardia 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
Cardiogenic shock 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
Long QT syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Mitral valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Myocardial fibrosis 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
Nodal arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Sinus node dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Trifascicular block 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
Lown-Ganong-Levine syndrome SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 20 View
Spinocerebellar ataxia SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 20 View
Deafness neurosensory SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 20 View
Thyroid mass SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 20 View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20 View
Macular degeneration SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20 View
Retinal artery occlusion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20 View
Abdominal incarcerated hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Anal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Bloody peritoneal effluent SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Colitis microscopic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Diverticulum intestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Gastric antral vascular ectasia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Gastric haemorrhage 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
Gastritis haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Intestinal ischaemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Oedematous pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Reactive gastropathy 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
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Tongue haemorrhage 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
Cardiac death SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Catheter site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Complication associated with device SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Malaise 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
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20 View
Biliary colic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20 View
Hepatic cirrhosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20 View
Hepatic congestion SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20 View
Hepatitis toxic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20 View
Jaundice cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20 View
Liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20 View
Portal vein thrombosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20 View
Anti-neutrophil cytoplasmic antibody positive vasculitis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 20 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 20 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 20 View
Renal transplant failure SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 20 View
Sarcoidosis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 20 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Acute hepatitis B SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Bacterial pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Bronchitis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Catheter site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Clostridium colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Device related sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Enterococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Enterocolitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Escherichia pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Escherichia sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Gastritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Groin abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Hepatic cyst infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Hepatitis B SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Klebsiella sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Lymphangitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Nosocomial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Oesophageal candidiasis 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
Parotitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Peritonitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Post procedural sepsis 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 acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Pyelonephritis chronic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Renal cyst infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Salpingo-oophoritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Staphylococcal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Streptococcal endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Tubo-ovarian abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Upper respiratory tract infection bacterial 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
Urinary tract infection enterococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Urinary tract infection pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Arterial bypass occlusion 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 site haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Arteriovenous fistula thrombosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Brain contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Chest injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Complications of transplanted kidney 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
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Multiple injuries SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Peritoneal dialysis complication 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
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Shunt malfunction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Shunt occlusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Skin injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Splenic rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Synovial rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Tendon rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Toxicity to various agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Traumatic intracranial haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Urinary anastomotic leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Vascular access malfunction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Vascular access site bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Vascular access site swelling SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Vascular access site thrombosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Vascular pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20 View
Blood potassium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20 View
Blood sodium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20 View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20 View
Occult blood positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 20 View
Alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Alkalosis hypochloraemic SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 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
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
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Hypochloraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Iron deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Mineral deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20 View
Gouty arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20 View
Acute myeloid leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Adenocarcinoma gastric SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Adenocarcinoma of colon 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
Benign neoplasm of thyroid gland SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Benign renal neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Breast cancer stage I SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Carcinoma in situ of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Chronic myelomonocytic leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Hepatocellular carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Meningioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Metastases to bone SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Metastases to lung SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Metastasis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Oesophageal adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Parathyroid tumour benign 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
Small cell lung cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Uterine neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20 View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Central nervous system lesion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Cerebral ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Coma 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
Encephalopathy 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
Hypoglycaemic coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Hypoglycaemic unconsciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Hypoxic-ischaemic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Lumbar radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Partial seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Simple partial seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Thalamus haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Uraemic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Device dislocation SYSTEMATIC_ASSESSMENT Product Issues MedDRA 20 View
Device leakage SYSTEMATIC_ASSESSMENT Product Issues MedDRA 20 View
Alcoholism SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20 View
Frustration tolerance decreased 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
Anuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Azotaemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Chronic kidney disease 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
Nephropathy toxic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Obstructive uropathy SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Renal artery stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Renal cyst haemorrhage SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Renal cyst ruptured SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Ureterolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Urinary bladder rupture SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Menometrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20 View
Ovarian cyst 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
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Bronchopulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Emphysema 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
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Pulmonary fibrosis 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
Pulmonary vasculitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Respiratory arrest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20 View
Diabetic foot SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20 View
Panniculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20 View
Toxic epidermal necrolysis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20 View
Aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Aortic intramural haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Blood pressure fluctuation SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Circulatory collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Embolism arterial SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Extremity necrosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Hypertensive emergency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Hypovolaemic shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Iliac artery occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Peripheral artery occlusion 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
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Shock haemorrhagic SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Venous thrombosis limb SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 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
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Iron deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View