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The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
All the patients whom an investigator prescribes Crizotinib (XALKORI) should be registered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crizotinib (Xalkori) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crizotinib (Xalkori) | Drug | XALKORI® Capsule 200 mg／XALKORI® Capsule 250 mg This surveillance is all cases surveillance based on Japanese regulation. Frequency and duration are according to Package Insert as follows. " The recommended dose schedule of crizotinib is 250 mg taken orally twice daily. Dosing interruption and/or dose reduction may be required based on patients' clinical status. " |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Drug Reactions | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XALKORI Capsules in a participant who received XALKORI Capsules. A serious ADR was a ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XALKORI Capsules was assessed by the physician. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) at 52 Weeks | Clinical effectiveness of XALKORI Capsules was assessed as "complete response (CR)", "partial response (PR)", "stable disease (SD)", "progressive disease (PD)", or "indeterminate" by the physician, based on Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1. Overall effectiveness of XALKORI Capsules was determined by the physician based on the best response. Clinical effectiveness rate was ORR, defined as the percentage of subjects achieving CR or PR with best response. The ORR was presented along with the corresponding exact 2-sided 95% confidence interval (CI). |
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Inclusion Criteria:
Exclusion Criteria:
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The patients whom an investigator involving A8081031 prescribes the Crizotinib (XALKORI).
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31008509 | Derived | Ueno N, Banno S, Endo Y, Tamura M, Sugaya K, Hashigaki S, Ohki E, Yoshimura A, Gemma A. Treatment status and safety of crizotinib in 2028 Japanese patients with ALK-positive NSCLC in clinical settings. Jpn J Clin Oncol. 2019 Jul 1;49(7):676-686. doi: 10.1093/jjco/hyz049. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | XALKORI Capsules (Crizotinib) | Participants who received XALKORI Capsules as indicated in the approved local product document were observed for a period of 52 weeks. The dosage can be adjusted as per physician's discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 2029 participants were completed this study. Of the 2029 participants, 1 participant was excluded from the safety analysis set due to no drug administration.
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| ID | Title | Description |
|---|---|---|
| BG000 | XALKORI Capsules (Crizotinib) | Participants who received XALKORI Capsules as indicated in the approved local product document were observed for a period of 52 weeks. The dosage can be adjusted as per physician's discretion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Drug Reactions | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XALKORI Capsules in a participant who received XALKORI Capsules. A serious ADR was a ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XALKORI Capsules was assessed by the physician. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received XALKORI Capsules at least once. | Posted | Number | Participants | 52 weeks |
|
52 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | XALKORI Capsules (Crizotinib) | Participants who received XALKORI Capsules as indicated in the approved local product document were observed for a period of 52 weeks. The dosage can be adjusted as per physician's discretion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Venous thrombosis limb | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysgeusia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 27, 2012 | Jul 14, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 1, 2017 | Jul 14, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077547 | Crizotinib |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000631 | Aminopyridines |
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|
|
| 52 weeks |
| Participants |
|
| Sex/Gender, Customized | Number | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | Objective Response Rate (ORR) at 52 Weeks | Clinical effectiveness of XALKORI Capsules was assessed as "complete response (CR)", "partial response (PR)", "stable disease (SD)", "progressive disease (PD)", or "indeterminate" by the physician, based on Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1. Overall effectiveness of XALKORI Capsules was determined by the physician based on the best response. Clinical effectiveness rate was ORR, defined as the percentage of subjects achieving CR or PR with best response. The ORR was presented along with the corresponding exact 2-sided 95% confidence interval (CI). | The efficacy analysis set (EAS) is comprised in the safety analysis set who had at least one measurable lesion and were evaluated for effectiveness. 1633 participants were included in the EAS. | Posted | Number | 95% Confidence Interval | Percentage of participants | 52 weeks |
|
|
|
| 436 |
| 2,028 |
| 777 |
| 2,028 |
| 1,783 |
| 2,028 |
| Vena cava thrombosis | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Thrombophlebitis superficial | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Peripheral circulatory failure | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Embolism venous | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Neurogenic bladder | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Bladder disorder | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Paraneoplastic neurological syndrome | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Myasthenia gravis | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Leukoencephalopathy | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hemiplegia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Guillain-Barre syndrome | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Facial paralysis | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Drug withdrawal convulsions | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Second primary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Intracranial tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Anaplastic large-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Muscle atrophy | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Renal function test abnormal | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Electrocardiogram T wave abnormal | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Renal cyst infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Renal abscess | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Psoas abscess | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumonia pneumococcal | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumonia influenzal | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumonia herpes viral | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Perinephric abscess | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Muscle abscess | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Mediastinitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Lung abscess | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Kidney infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Infective exacerbation of bronchiectasis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastroenteritis salmonella | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Atypical pneumonia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hepatitis fulminant | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hepatic necrosis | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Biliary dilatation | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Sudden death | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Face oedema | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Drug interaction | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Oesophageal perforation | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Oesophageal pain | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Oesophageal fistula | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Necrotising oesophagitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastrointestinal oedema | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Anorectal disorder | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Macular hole | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Eye disorder | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Tracheo-oesophageal fistula | Congenital, familial and genetic disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Long QT syndrome | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Conduction disorder | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Colour blindness | Congenital, familial and genetic disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Congenital cystic kidney disease | Congenital, familial and genetic disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Abnormal sensation in eye | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Accommodation disorder | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cataract subcapsular | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Extraocular muscle paresis | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Eye disorder | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypermetropia | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Night blindness | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Optic nerve disorder | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Periorbital oedema | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Punctate keratitis | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Retinal tear | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Anal inflammation | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Chronic gastritis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dumping syndrome | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Faeces soft | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastrointestinal mucosal disorder | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastrointestinal oedema | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Intestinal dilatation | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Lip erosion | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Oesophageal pain | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Oral dysaesthesia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pancreatic cyst | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Face oedema | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Infusion site extravasation | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Localised oedema | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Sensation of foreign body | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hepatic cyst | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Abscess oral | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Angular cheilitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Atypical mycobacterial infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Enterocolitis bacterial | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Lung abscess | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Oropharyngeal candidiasis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Skin candida | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Chest injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Chillblains | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Closed globe injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Radiation oesophagitis | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Recall phenomenon | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Tracheal haemorrhage | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Beta 2 microglobulin increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood chloride decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood chloride increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood urea abnormal | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Carbohydrate antigen 19-9 increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Carcinoembryonic antigen increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Cardioactive drug level increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Cell marker increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Chest X-ray abnormal | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Creatinine renal clearance decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Granulocyte count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Grip strength decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Investigation abnormal | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Lymphocyte count increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Monocyte count increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Nutritional condition abnormal | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Prothrombin time prolonged | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Renal function test abnormal | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Tumour marker increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Vitamin B12 decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Glomerular filtration rate decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Red blood cell count increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hyperchloraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hyperphosphatasaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypozincaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Zinc deficiency | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Fibrous histiocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Intestinal metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Intracranial tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Lymphangiosis carcinomatosa | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Metastases to adrenals | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dyslalia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Facial neuralgia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Muscle spasticity | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Nervous system disorder | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Neurotoxicity | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pyramidal tract syndrome | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Trigeminal nerve disorder | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Visual field defect | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Visual perseveration | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Affective disorder | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Anticipatory anxiety | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Anxiety disorder | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dissociative disorder | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dysphoria | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Mood altered | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Neurosis | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Glomerulonephritis chronic | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Mesangioproliferative glomerulonephritis | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Nephropathy toxic | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Neurogenic bladder | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Prerenal failure | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Renal vein thrombosis | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Urethral stenosis | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dysaesthesia pharynx | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Laryngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Laryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Obliterative bronchiolitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pharyngeal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Asteatosis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dermatomyositis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Erythema annulare | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Livedo reticularis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Mechanical urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Eczema nummular | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Superior vena cava syndrome | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hepatobiliary disease | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Parosmia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011725 |
| Pyridines |