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 @ 1:35 PM
Ignite Modification Date:
2025-12-25 @ 12:35 PM
NCT ID:
NCT01210495
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Frequency Threshold:
5
Time Frame:
Baseline up to follow-up visit (up to 6 years)
Study:
NCT01210495
Study Brief:
Axitinib For The Treatment Of Advanced Hepatocellular Carcinoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Child-Pugh Class A | Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID. | None | None | 10 | 15 | 15 | 15 | View |
| Child-Pugh Class B | Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non randomized portion of this study to determine the recommended starting dose of axitinib for this population. | None | None | 3 | 7 | 7 | 7 | View |
| Axitinib | Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). | None | None | 62 | 133 | 130 | 133 | View |
| Placebo | Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study. | None | None | 16 | 68 | 55 | 68 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v17.0) | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (v17.0) | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (v17.0) | View |
| Acute myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (v17.0) | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (v17.0) | View |
| Ventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (v17.0) | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (v17.0) | View |
| Retinal vein occlusion | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (v17.0) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Ascites | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Enterocolitis haemorrhagic | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Gastric ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Gastrointestinal disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Rectal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Varices oesophageal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Upper gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v17.0) | View |
| Disease progression | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v17.0) | View |
| General physical health deterioration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v17.0) | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v17.0) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v17.0) | View |
| Bile duct stenosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (v17.0) | View |
| Cholangitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (v17.0) | View |
| Cholecystitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (v17.0) | View |
| Hepatic failure | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (v17.0) | View |
| Hepatic function abnormal | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (v17.0) | View |
| Hepatorenal syndrome | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (v17.0) | View |
| Jaundice cholestatic | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (v17.0) | View |
| Abscess rupture | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v17.0) | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v17.0) | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v17.0) | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v17.0) | View |
| Ovarian abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v17.0) | View |
| Peritonitis bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v17.0) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v17.0) | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v17.0) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v17.0) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v17.0) | View |
| Femur fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v17.0) | View |
| Humerus fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v17.0) | View |
| Road traffic accident | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v17.0) | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v17.0) | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v17.0) | View |
| Cachexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v17.0) | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v17.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v17.0) | View |
| Electrolyte imbalance | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v17.0) | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v17.0) | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v17.0) | View |
| Hypovolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v17.0) | View |
| Muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v17.0) | View |
| Necrotising myositis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v17.0) | View |
| Osteoporotic fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v17.0) | View |
| Hepatocellular carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (v17.0) | View |
| Malignant neoplasm progression | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (v17.0) | View |
| Tumour rupture | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (v17.0) | View |
| Brain stem infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v17.0) | View |
| Cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v17.0) | View |
| Coma hepatic | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v17.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v17.0) | View |
| Encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v17.0) | View |
| Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v17.0) | View |
| Hepatic encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v17.0) | View |
| Ischaemic stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v17.0) | View |
| Quadriparesis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v17.0) | View |
| Completed suicide | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v17.0) | View |
| Dysthymic disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v17.0) | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (v17.0) | View |
| Renal impairment | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (v17.0) | View |
| Ureteric obstruction | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (v17.0) | View |
| Bronchospasm | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v17.0) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v17.0) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v17.0) | View |
| Lung disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v17.0) | View |
| Obstructive airways disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v17.0) | View |
| Pulmonary alveolar haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v17.0) | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v17.0) | View |
| Drug eruption | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v17.0) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (v17.0) | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (v17.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v17.0) | View |
| Bile duct stone | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (v17.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (v17.0) | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (v17.0) | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (v17.0) | View |
| Hydrocele | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (v17.0) | View |
| Ear disorder | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (v17.0) | View |
| Hypothyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (v17.0) | View |
| Ocular surface disease | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (v17.0) | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Anal inflammation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Ascites | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Enterocolitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Gastritis erosive | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Glossitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Varices oesophageal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v17.0) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v17.0) | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v17.0) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v17.0) | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v17.0) | View |
| Face oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v17.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v17.0) | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v17.0) | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v17.0) | View |
| Mucosal inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v17.0) | View |
| Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v17.0) | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v17.0) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v17.0) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v17.0) | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (v17.0) | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v17.0) | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v17.0) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v17.0) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v17.0) | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v17.0) | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v17.0) | View |
| Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v17.0) | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v17.0) | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v17.0) | View |
| Alpha 1 foetoprotein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v17.0) | View |
| Ammonia increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v17.0) | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v17.0) | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v17.0) | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v17.0) | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v17.0) | View |
| Blood thyroid stimulating hormone increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v17.0) | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v17.0) | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v17.0) | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v17.0) | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v17.0) | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v17.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v17.0) | View |
| Hypercalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v17.0) | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v17.0) | View |
| Hypoalbuminaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v17.0) | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v17.0) | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v17.0) | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v17.0) | View |
| Hypophosphataemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v17.0) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v17.0) | View |
| Arthropathy | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v17.0) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v17.0) | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v17.0) | View |
| Flank pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v17.0) | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v17.0) | View |
| Muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v17.0) | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v17.0) | View |
| Musculoskeletal chest pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v17.0) | View |
| Musculoskeletal discomfort | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v17.0) | View |
| Musculoskeletal stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v17.0) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v17.0) | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v17.0) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v17.0) | View |
| Tumour associated fever | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (v17.0) | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v17.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v17.0) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v17.0) | View |
| Hepatic encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v17.0) | View |
| Neuropathy peripheral | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v17.0) | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v17.0) | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v17.0) | View |
| Agitation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v17.0) | View |
| Confusional state | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v17.0) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v17.0) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v17.0) | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v17.0) | View |
| Chromaturia | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (v17.0) | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (v17.0) | View |
| Pollakiuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (v17.0) | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (v17.0) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v17.0) | View |
| Dysphonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v17.0) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v17.0) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v17.0) | View |
| Haemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v17.0) | View |
| Interstitial lung disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v17.0) | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v17.0) | View |
| Nasal inflammation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v17.0) | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v17.0) | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v17.0) | View |
| Upper respiratory tract inflammation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v17.0) | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v17.0) | View |
| Blister | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v17.0) | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v17.0) | View |
| Facial wasting | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v17.0) | View |
| Nail disorder | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v17.0) | View |
| Night sweats | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v17.0) | View |
| Palmar-plantar erythrodysaesthesia syndrome | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v17.0) | View |
| Petechiae | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v17.0) | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v17.0) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v17.0) | View |
| Skin ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v17.0) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (v17.0) | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (v17.0) | View |
| Catheter site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v17.0) | View |