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 @ 7:19 PM
Ignite Modification Date:
2025-12-25 @ 4:58 PM
NCT ID:
NCT00460603
Description:
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00460603
Study Brief:
Study With AG-013736 Combined With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 2) | Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion. | None | None | 2 | 6 | 6 | 6 | View |
| Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 3) | Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion. | None | None | 2 | 4 | 4 | 4 | View |
| Phase 1: Axitinib + FOLFIRI (Cohort 4) | FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion. | None | None | 3 | 8 | 8 | 8 | View |
| Phase 1: Axitinib + FOLFOX (Cohort 5) | FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion. | None | None | 5 | 6 | 6 | 6 | View |
| Phase 1: Axitinib + FOLFIRI (Cohort 6) | FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion. | None | None | 1 | 4 | 4 | 4 | View |
| Phase 1: Axitinib + FOLFOX (Cohort 7) | FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion. | None | None | 1 | 6 | 6 | 6 | View |
| Phase 1: Axitinib + FOLFIRI (Cohort 8) | Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion. | None | None | 1 | 3 | 3 | 3 | View |
| Phase 1: Axitinib + FOLFOX (Cohort 9) | Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion. | None | None | 8 | 18 | 18 | 18 | View |
| Phase 2: Axitinib + FOLFOX | FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion. | None | None | 15 | 39 | 39 | 39 | View |
| Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 1) | Bevacizumab 1 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion. | None | None | 3 | 6 | 6 | 6 | View |
| Phase 2: Bevacizumab + FOLFOX | Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion. | None | None | 17 | 43 | 42 | 43 | View |
| Phase 2: Axitinib + Bevacizumab + FOLFOX | Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion. | None | None | 23 | 41 | 39 | 41 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrointestinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Melaena | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.1) | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.1) | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.1) | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.1) | View |
| Cardiac failure congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.1) | View |
| Cardiomyopathy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.1) | View |
| Left ventricular dysfunction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.1) | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.1) | View |
| Sinus bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.1) | View |
| Blindness | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Diverticular perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Enteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Gastric ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Gastric ulcer haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Proctalgia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Small intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Disease progression | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Mucosal inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Cholangitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.1) | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.1) | View |
| Cholecystitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.1) | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.1) | View |
| Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (15.1) | View |
| Abscess intestinal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Abdominal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Bacterial sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Device related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Rectal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Sepsis syndrome | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Septic shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Staphylococcal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Lower limb fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Procedural haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Toxicity to various agents | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Wound dehiscence | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Hepatic enzyme increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| International normalised ratio increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Malnutrition | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Fistula | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Altered state of consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Cerebral haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Haemorrhage intracranial | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Hemiparesis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Peripheral motor neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Speech disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Confusional state | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.1) | View |
| Mental status changes | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.1) | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.1) | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.1) | View |
| Renal failure acute | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.1) | View |
| Testicular pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (15.1) | View |
| Acute respiratory distress syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Acute respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Pulmonary fibrosis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Aortic thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Jugular vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Orthostatic hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Shock haemorrhagic | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Subclavian vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Superior vena cava syndrome | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypercoagulation | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.1) | View |
| Leukocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.1) | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.1) | View |
| Lymph node pain | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.1) | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.1) | View |
| Microcytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.1) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.1) | View |
| Pancytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.1) | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.1) | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.1) | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.1) | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.1) | View |
| Left ventricular dysfunction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.1) | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.1) | View |
| Deafness | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (15.1) | View |
| Ear discomfort | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (15.1) | View |
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (15.1) | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (15.1) | View |
| Hypothyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (15.1) | View |
| Blepharospasm | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |
| Conjunctival haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |
| Dry eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |
| Eye discharge | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |
| Eye irritation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |
| Photophobia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |
| Retinal vein occlusion | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |
| Vision blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Abdominal pain lower | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Abdominal rigidity | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Abdominal tenderness | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Gastrointestinal sounds abnormal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Glossitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Glossodynia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Hypoaesthesia oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Lip blister | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Loose tooth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Mesenteric vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Mouth ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Oesophageal stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Oral pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Paraesthesia oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Proctalgia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Rectal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Retching | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Salivary hypersecretion | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Swollen tongue | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Tongue disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Axillary pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Catheter site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Catheter site haematoma | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Catheter site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Device dislocation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Device occlusion | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Early satiety | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Face oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Gait disturbance | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Hernia pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Impaired healing | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Local swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Mucosal inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Nodule | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Temperature intolerance | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Thrombosis in device | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Cholangitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.1) | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.1) | View |
| Hepatic pain | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.1) | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.1) | View |
| Jaundice | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.1) | View |
| Portal vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.1) | View |
| Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (15.1) | View |
| Arthropod-borne disease | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Enterobacter sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Escherichia urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Eye infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Furuncle | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Fungal skin infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Gastrointestinal viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Herpes virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Incision site infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Laryngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Oral candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Rectal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Subcutaneous abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Tinea infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Tooth infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Urosepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Vulvovaginal mycotic infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Anal injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Burns second degree | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Excoriation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Lower limb fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Procedural site reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Skeletal injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Tooth fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Wound dehiscence | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Blood lactate dehydrogenase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Blood magnesium decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Blood potassium decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Blood pressure diastolic decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Blood pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Blood testosterone decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Blood thyroid stimulating hormone increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Blood uric acid increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Breath sounds abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Cardiac enzymes increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| International normalised ratio increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Cachexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Hypernatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Hyperuricaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Hypoalbuminaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Hypomagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Hypophosphataemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Hypovolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Malnutrition | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Metabolic acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Bursa disorder | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Flank pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Musculoskeletal chest pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Musculoskeletal stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Pain in jaw | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Trigger finger | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Ageusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Aphasia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Ataxia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Hyperaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| IIIrd nerve disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Lethargy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Memory impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Mononeuritis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Neuropathy peripheral | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Neuralgia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Peripheral motor neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Restless legs syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Transient ischaemic attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.1) | View |
| Claustrophobia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.1) | View |
| Confusional state | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.1) | View |
| Delirium | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.1) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.1) | View |
| Disorientation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.1) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.1) | View |
| Mood altered | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.1) | View |
| Sleep disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.1) | View |
| Chromaturia | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.1) | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.1) | View |
| Glycosuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.1) | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.1) | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.1) | View |
| Pollakiuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.1) | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.1) | View |
| Urinary hesitation | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.1) | View |
| Urinary incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.1) | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.1) | View |
| Amenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (15.1) | View |
| Genital rash | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (15.1) | View |
| Apnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Dysphonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Dyspnoea exertional | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Hiccups | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Paranasal sinus hypersecretion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Pleurisy | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Pulmonary haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Rhinitis allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Sinus congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Tachypnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Upper-airway cough syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Blister | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Decubitus ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Facial wasting | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Nail disorder | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Night sweats | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Palmar-plantar erythrodysaesthesia syndrome | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Palmar erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Plantar erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Rash erythematous | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Rash generalised | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Rash macular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Skin burning sensation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Intermittent claudication | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Orthostatic hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Pallor | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.1) | View |
| Tooth abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Wound complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.1) | View |
| Ear pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (15.1) | View |
| Hypoacusis | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (15.1) | View |
| Eye pain | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |
| Lacrimation increased | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.1) | View |
| Adverse drug reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Catheter site infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Paranoia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.1) | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.1) | View |
| Urethral haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.1) | View |
| Urge incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.1) | View |
| Nasal discomfort | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Nasal disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Nasal dryness | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Ecchymosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Skin discolouration | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Skin exfoliation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Skin irritation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Skin hyperpigmentation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.1) | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.1) | View |
| Anaemia megaloblastic | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.1) | View |