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 @ 4:48 PM
Ignite Modification Date:
2025-12-25 @ 2:33 PM
NCT ID:
NCT02865850
Description:
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0016 (NCT02865850). Of the participants randomized, 365 participants were included in the Safety population (179 and 186 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Four randomized participants did not receive treatment.
Frequency Threshold:
0
Time Frame:
Up to 176 weeks
Study:
NCT02865850
Study Brief:
Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Vadadustat | Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels. | 15 | None | 89 | 179 | 79 | 179 | View |
| Darbepoetin Alfa | Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen. | 20 | None | 105 | 186 | 83 | 186 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrointestinal inflammation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Gastrointestinal polyp haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Haemorrhagic erosive gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Large intestine perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Proctitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 22.1 | View |
| Cardiac death | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 22.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 22.1 | View |
| Sudden cardiac death | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 22.1 | View |
| Systemic inflammatory response syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 22.1 | View |
| Biliary colic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 22.1 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 22.1 | View |
| Hepatic congestion | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 22.1 | View |
| Porcelain gallbladder | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 22.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Bacterial sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Breast abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Catheter site abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Cellulitis staphylococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Clostridium difficile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Cytomegalovirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Cytomegalovirus syndrome | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Diabetic foot infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Enterococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Intervertebral discitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Klebsiella infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Localised infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Osteomyelitis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Parotitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Pharyngitis streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Pneumonia bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Pneumonia mycoplasmal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Pneumonia staphylococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Renal cyst infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Serratia bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Staphylococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Subacute endocarditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Tracheobronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Vascular access site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Wound abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Arteriovenous fistula site haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Arteriovenous graft thrombosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Lower limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Lumbar vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Multiple injuries | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Muscle injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Periprosthetic fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Peritoneal dialysis complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Post procedural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Soft tissue injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Subdural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Traumatic intracranial haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Vascular access malfunction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Wound dehiscence | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Wound necrosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 22.1 | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 22.1 | View |
| Cachexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 22.1 | View |
| Diabetes mellitus inadequate control | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 22.1 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 22.1 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 22.1 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 22.1 | View |
| SLE arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 22.1 | View |
| Systemic lupus erythematosus | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 22.1 | View |
| Choroid melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.1 | View |
| Hepatocellular carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.1 | View |
| Lip squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.1 | View |
| Metastases to spine | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.1 | View |
| Neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.1 | View |
| Ovarian neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.1 | View |
| Aphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.1 | View |
| Brain injury | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.1 | View |
| Brain stem syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.1 | View |
| Cerebral haematoma | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.1 | View |
| Cerebral hypoperfusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.1 | View |
| Embolic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.1 | View |
| Lacunar infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.1 | View |
| Myoclonus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.1 | View |
| Postresuscitation encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.1 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.1 | View |
| Subarachnoid haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.1 | View |
| Pre-eclampsia | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDra 22.1 | View |
| Device occlusion | SYSTEMATIC_ASSESSMENT | Product Issues | MedDra 22.1 | View |
| Bipolar I disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 22.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 22.1 | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 22.1 | View |
| Uterine polyp | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDra 22.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.1 | View |
| Hydrothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.1 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.1 | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.1 | View |
| Pulmonary artery thrombosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.1 | View |
| Pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.1 | View |
| Sleep apnoea syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.1 | View |
| Vocal cord leukoplakia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.1 | View |
| Blister | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 22.1 | View |
| Hidradenitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 22.1 | View |
| Hospitalisation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.1 | View |
| Accelerated hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Aortic aneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Aortic stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Brachiocephalic vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Extremity necrosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Jugular vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Malignant hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Peripheral arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Shock haemorrhagic | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Steal syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Superior vena cava syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Thrombophlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Venous thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Gangrene | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Staphylococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.1 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Acute pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 22.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Pancreatitis acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Hepatitis B | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Vascular access site thrombosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 22.1 | View |
| Pulseless electrical activity | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Arteriovenous fistula site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Device related sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Vascular device infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 22.1 | View |
| Diabetic ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 22.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 22.1 | View |
| Hypervolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 22.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 22.1 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.1 | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.1 | View |
| Blood loss anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 22.1 | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Cardiac failure chronic | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Cardiogenic shock | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Chronic gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Gastritis erosive | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Impaired gastric emptying | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Complication associated with device | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 22.1 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 22.1 | View |
| Impaired healing | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 22.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 22.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 22.1 | View |
| Acute hepatitis B | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Arteriovenous graft site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Renal graft infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Staphylococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Pelvic fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 22.1 | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.1 | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 22.1 | View |
| Azotaemia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 22.1 | View |
| End stage renal disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 22.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.1 | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 22.1 | View |
| Arteriosclerosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Hypertensive emergency | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Peripheral ischaemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Peripheral vascular disorder | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Blood disorder | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 22.1 | View |
| Pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 22.1 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Aortic valve stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Atrial tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Atrioventricular block complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Bundle branch block left | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Bundle branch block right | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Cardiac failure acute | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Cardiac valve disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Chronic left ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Coronary artery stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Ischaemic cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Left ventricular dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Left ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Myocardial ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDra 22.1 | View |
| Angle closure glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 22.1 | View |
| Diabetic retinopathy | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 22.1 | View |
| Retinal artery thrombosis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 22.1 | View |
| Abdominal migraine | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Diarrhoea haemorrhagic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Diverticular perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Dolichocolon acquired | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Duodenal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Duodenal ulcer haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Duodenal ulcer perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Faecaloma | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Gastric haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Gastric ulcer haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.1 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.1 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 22.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Fluid overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 22.1 | View |
| Hypertensive urgency | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Arteriovenous fistula thrombosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 22.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Procedural hypotension | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Dialysis related complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 22.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.1 | View |