Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2026-02-24 @ 3:16 PM
Study NCT ID:
NCT02156895
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2014-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post Marketing Surveillance Study to Observe Safety and Efficacy of Inlyta in South Korea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077784', 'term': 'Axitinib'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants who had been administered Inlyta at least once and evaluated for safety related outcomes at least once.', 'eventGroups': [{'id': 'EG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.', 'otherNumAtRisk': 111, 'deathsNumAtRisk': 111, 'otherNumAffected': 92, 'seriousNumAtRisk': 111, 'deathsNumAffected': 2, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Eustachian tube patulous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 10}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Proctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ecthyma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Endometritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Liver function test increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Thyroid function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Neurogenic bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ejaculation failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Perineal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oropharyngeal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hand dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Palmoplantar keratoderma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Palmoplantar pustulosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sebaceous hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 23}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': 'ADRs', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'SADRs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Inlyta in a participant who received Inlyta. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Inlyta was assessed by the physician.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were administered Inlyta at least once and evaluated for safety related outcomes at least once.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'classes': [{'title': 'Unexpected AEs', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Unexpected ADRs', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Unexpected SAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Unexpected SADRs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': "An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Inlyta in a participant who received Inlyta. SADR was any SAE that is attributed to Inlyta. Relatedness to Inlyta was assessed by the physician. An unexpected AE was an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug. Unexpected ADRs were unexpected AEs that were, in the investigator's opinion, of causal relationship to the study treatment.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were administered Inlyta at least once and evaluated for safety related outcomes at least once.'}, {'type': 'PRIMARY', 'title': 'Duration of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '475'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were administered Inlyta at least once and evaluated for safety related outcomes at least once. Here, "Overall Number of Participants Analyzed" signifies number of participants without missing date or month of AE onset.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events by Their Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Severity was graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 where, Grade 1: mild; Grade 2: moderate; Grade 3:severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. One participant may experience more than one event hence, one participant may be included in more than one category specified below.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were administered Inlyta at least once and evaluated for safety related outcomes at least once. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events by Their Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'classes': [{'title': 'Recovered', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'Recovered with sequelae', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Recovering', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Not recovered', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The outcomes of AE included recovered, recovered with sequelae, recovering, not recovered and unknown. One participant may experience more than one event hence one participant may be included in more than one category specified below.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were administered Inlyta at least once and evaluated for safety related outcomes at least once. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events by Their Seriousness Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'classes': [{'title': 'Results in death', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Is life-threatening', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Requires inpatient hospitalization or prolongation of hospitalization', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Results in persistent or significant disability/incapacity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Results in congenital anomaly/birth defect', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other important medical event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The seriousness criteria for AEs included results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect, other important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were administered Inlyta at least once and evaluated for safety related outcomes at least once. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events by Their Causality to Inlyta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'classes': [{'title': 'Certain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Probable/likely', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Possible', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}, {'title': 'Unlikely', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Conditional/unclassified', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Unaccessible/unclassifiable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship. The causality of AEs to Inlyta were assessed by physician according to the following criteria: certain, probable/likely, possible, unlikely, conditional/unclassified and unaccessible/unclassifiable. One participant may experience more than one event hence, one participant may be included in more than one category specified below.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were administered Inlyta at least once and evaluated for safety related outcomes at least once. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events by Their Other Causality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'classes': [{'title': 'Disease under the study', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Other disease', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Concomitant treatment drug or non-drug', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Others', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. If the AEs were not related to Inlyta, physicians were required to indicate the most appropriate cause of AEs from the following: disease under the study, other disease, concomitant treatment drug or non-drug and others.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were administered Inlyta at least once and evaluated for safety related outcomes at least once. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events by Their Action Taken With Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'classes': [{'title': 'Discontinuation', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Dosage reduced', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Not applicable', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The action taken with study drug due to AEs included discontinuation, dosage reduced, no change, unknown and not applicable. One participant may experience more than one event hence, one participant may be included in more than one category specified below.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were administered Inlyta at least once and evaluated for safety related outcomes at least once. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events According to Demographic Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'classes': [{'title': 'Sex: Male', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}]}]}, {'title': 'Sex: Female', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Age: < 60 years', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Age: >= 60 years and < 70 years', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Age: >= 70 years', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Pediatric(< 19 years)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Geriatric(>= 65 years)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'Classification: Outpatient', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}, {'title': 'Classification: Inpatient', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Number of participants with AEs classified according to the following demographic characteristics: sex: male and female; age: less than (\\<) 60 years, greater than or equal to (\\>=) 60 and \\< 70 years and \\>= 70 years; pediatric (\\<19 years); geriatric (\\>=65 years); classification: outpatient and inpatient were reported in the outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were administered Inlyta at least once and evaluated for safety related outcomes at least once. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events According to Other Baseline Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'classes': [{'title': 'Duration of aRCC: < 30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}, {'title': 'Duration of aRCC: >= 30 months and < 60 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Duration of aRCC: >= 60 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Cell component of aRCC: Clear cell', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': 'Cell component of aRCC: Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Metastasis: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Metastasis: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Metastasis site: Liver', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Metastasis site: Lung', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Metastasis site: Bone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Metastasis site: Brain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Metastasis site: Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Metastasis site: Lymph nodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Metastasis site: Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Primary lesion surgery: Done', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}, {'title': 'Primary lesion surgery: Not done', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Medical history: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}, {'title': 'Medical history: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Renal impairment: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Renal impairment: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}]}]}, {'title': 'Hepatic impairment: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Hepatic impairment: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'Allergic history: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Allergic history: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}, {'title': 'Prior chemotherapy: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': 'Prior chemotherapy: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Prior immunotherapy: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Prior immunotherapy: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': 'Prior radiation therapy: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Prior radiation therapy: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}, {'title': 'Concomitant medication: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}, {'title': 'Concomitant medication: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Duration of administration: < 90 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Duration of administration: >= 90 days and <180 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Duration of administration: >= 180 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}, {'title': 'Daily average dose: < 10 mg/day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Daily average dose: >= 10 mg/day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Number of participants with AEs classified according to the following characteristics: duration of aRCC: \\< 30 months, \\>= 30 months and \\< 60 months,\\>= 60 months; cell component of aRCC : clear cell ,other; metastasis: yes,no; site of metastasis: liver, lung, bone, brain, skin, lymph nodes, other; primary lesion surgery: done and not done; medical history: yes and no; renal impairment: yes and no; hepatic impairment: yes and no; allergic history: yes and no; prior chemotherapy: yes and no; prior immunotherapy: yes and no; prior radiation therapy: yes and no; concomitant medication: yes and no; duration of administration: \\< 90 days, \\>=90 and \\<180 days and \\>= 180 days; daily average dose: \\<10 and \\>=10 milligrams per day (mg/day).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were administered Inlyta at least once and evaluated for safety related outcomes at least once. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. "Number Analyzed" refers to number of participants evaluable for the specified categories.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.1244', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.24', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Multiple logistic regression including total duration of treatment with Inlyta as factor'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were administered Inlyta at least once and evaluated for safety related outcomes at least once.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With AEs and ADRs - Special Participant Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'classes': [{'title': 'Geriatric - AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'Geriatric - ADRs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Renal impairment - AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Renal impairment - ADRs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Hepatic impairment - AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Hepatic impairment - ADRs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Inlyta in a participant who received Inlyta.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Special participant population included geriatric participants (aged \\>=65 years), participants with renal or hepatic impairment who were administered Inlyta at least once. "Number Analyzed" refers to number of participants evaluable for the specified categories.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Tumor Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'classes': [{'title': 'Complete response (CR)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Partial response (PR)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Progressive disease (PD)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Stable disease (SD)', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Not done', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of Inlyta up to first documented CR, PR, PD or SD, during observation period of the study of 9 years', 'description': 'Tumor response based on RECIST 1.1 was defined as: complete response (CR): complete disappearance of all target and non-target lesions. All lymph nodes must be non-pathological in size (\\<10 mm short axis); partial response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered a sign of progression; stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study and not done.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set included all participants who had been administered Inlyta at least once.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of Inlyta up to first documented CR or PR, during observation period of the study of 9 years', 'description': 'Objective response (OR) was defined as the achievement of partial or complete response to therapy based on RECIST 1.1. CR: complete disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\\<10 mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set included all participants who had been administered Inlyta at least once.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Objective Response According to Demographic Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'classes': [{'title': 'Sex: Male', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Sex: Female', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Age: < 60 years', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Age: >= 60 years and < 70 years', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Age: >= 70 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Pediatric(< 19 years)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Geriatric(>= 65 years)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Classification: Outpatient', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Classification: Inpatient', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of Inlyta up to first documented CR or PR, during observation period of the study of 9 years', 'description': 'OR was defined as the number of participants who have a partial or complete response to therapy. CR: complete disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\\<10 mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Number of participants with objective response categorized according to the following demographic characteristics was presented in this outcome measure: sex: male and female; age: \\< 60 years, \\>= 60 and \\< 70 years, \\>= 70 years; pediatric (\\<19 years); geriatric (\\>=65 years); classification: outpatient and inpatient.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set included all participants who had been administered Inlyta at least once. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Objective Response According to Other Baseline Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'classes': [{'title': 'Duration of aRCC: < 30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Duration of aRCC: >= 30 months and < 60 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Duration of aRCC: >= 60 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Cell component of aRCC: Clear cell', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Cell component of aRCC: Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Metastasis: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Metastasis: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Metastasis site: Liver', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Metastasis site: Lung', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Metastasis site: Bone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Metastasis site: Brain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Metastasis site: Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Metastasis site: Lymph nodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Metastasis site: Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Primary lesion surgery: Done', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Primary lesion surgery: Not done', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Medical history: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Medical history: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Renal impairment: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Renal impairment: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Hepatic impairment: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hepatic impairment: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Allergic history: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Allergic history: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Prior chemotherapy: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Prior chemotherapy: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Prior immunotherapy: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Prior immunotherapy: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Prior radiation therapy: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Prior radiation therapy: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Concomitant medication: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Concomitant medication: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Duration of administration: < 90 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Duration of administration: >= 90 days and <180 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Duration of administration: >= 180 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Daily average dose: < 10 mg/day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Daily average dose: >= 10 mg/day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of Inlyta up to first documented CR or PR, during observation period of the study of 9 years', 'description': 'OR was defined as the number of participants who have a partial or complete response to therapy. Number of participants with OR classified according to the following characteristics included duration of aRCC: \\< 30 months, \\>= 30 months and \\< 60 months and \\>= 60 months; cell component of aRCC : clear cell and other; metastasis: yes and no; site of metastasis: liver, lung, bone, brain, skin, lymph nodes and other; primary lesion surgery: done and not done; medical history: yes and no; renal impairment: yes and no; hepatic impairment: yes and no; allergic history: yes and no; prior chemotherapy: yes and no; prior immunotherapy: yes and no; prior radiation therapy: yes and no; concomitant medication: yes and no; duration of administration: \\< 90 days, \\>=90 and \\<180 days and \\>= 180 days; daily average dose: \\<10 and \\>=10 mg/day.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set included all participants who had been administered Inlyta at least once. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure. "Number Analyzed" refers to number of participants evaluable for the specified categories.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Objective Response - Multivariate Logistic Regression Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0109', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '1.02', 'ciUpperLimit': '1.2', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Multiple logistic regression including total duration of treatment with Inlyta as factor'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of Inlyta up to first documented CR or PR, during observation period of the study of 9 years', 'description': 'OR was defined as the achievement of partial or complete response to therapy based on RECIST 1.1. CR: complete disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\\<10 mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set included all participants who had been administered Inlyta at least once.'}, {'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'classes': [{'categories': [{'measurements': [{'value': '232.9', 'spread': '169.23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From first dose of Inlyta up to first documented tumor progression or death, whichever occurred first, during observation period of the study of 9 years', 'description': 'PFS was defined as the time from first dose of Inlyta to first documentation of objective tumor progression, or to death due to any cause, whichever occurred first. Tumor progression was determined from tumor assessment criteria(where data meet the criteria for progressive disease \\[PD\\]), or from death report on case report forms (CRFs). PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered a sign of progression.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set included all participants who had been administered Inlyta at least once.'}, {'type': 'PRIMARY', 'title': 'Time to Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'classes': [{'categories': [{'measurements': [{'value': '232.9', 'spread': '169.23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From first dose of Inlyta up to first documented disease progression or latest follow-up, during observation period of the study of 9 years', 'description': 'TTP was defined as the time from the start of Inlyta treatment to date of disease progression. If there was no progression, the case was censored as TTP at latest follow-up. Disease progression was defined as \\>20% increase in sum of longest diameter of target lesions compared to baseline.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set included all participants who had been administered Inlyta at least once.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 milligram (mg) or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants with advanced renal cell carcinoma (aRCC) prescribed with Inlyta (axitinib) for first time or who were already on Inlyta during study period as part of routine practice at Korean health care centers were observed. This study was to be conducted for 6 years from the approval date of 22 Aug 2012 to 21 Aug 2018. On May 2018, Ministry of Food and Drug Safety (MFDS) has granted 3 additional years for the study, for total of 9 years for the study period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Inlyta', 'description': 'Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '64.92', 'spread': '10.44', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Duration of Advanced Renal Cell Carcinoma (aRCC)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '46.84', 'spread': '55.21', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Duration of aRCC was calculated as the start date of first administration of Inlyta minus date of initial diagnosis + 1 divided by 30.4375.', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Participants Categorized According to Cell Component of aRCC', 'classes': [{'title': 'Clear cell', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Cell component of aRCC were classified as clear cell and other.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants According to Sites of Metastasis', 'classes': [{'title': 'Liver', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Lung', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}]}]}, {'title': 'Bone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}, {'title': 'Brain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Lymph nodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants according to the sites of metastasis including liver, lung, bone, brain, skin, lymph nodes, other and none were reported. Participants could have more than one site of metastasis.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants who Underwent Primary Lesion Surgery', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants With Medical History', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants with past or present disease (medical history) were reported in this study specific characteristic.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants With Renal Impairment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants With Hepatic Impairment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants With Allergic History', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants who Received Chemotherapy Prior to Inlyta', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants who received chemotherapy prior to Inlyta were reported.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants who Received Immunotherapy Prior to Inlyta', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants who received immunotherapy prior to Inlyta were reported.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants who Received Radiation Therapy Prior to Inlyta', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants who received radiation therapy prior to Inlyta were reported.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants who Received Concomitant Medication', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants who received concomitant medication were reported.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis set included all participants who were administered Inlyta at least once and evaluated for safety related outcomes at least once.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-19', 'size': 639683, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-08T17:23', 'hasProtocol': True}, {'date': '2021-07-21', 'size': 13109743, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-08-11T21:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-11', 'studyFirstSubmitDate': '2014-05-06', 'resultsFirstSubmitDate': '2022-08-11', 'studyFirstSubmitQcDate': '2014-06-03', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-11', 'studyFirstPostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Inlyta in a participant who received Inlyta. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Inlyta was assessed by the physician.'}, {'measure': 'Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': "An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Inlyta in a participant who received Inlyta. SADR was any SAE that is attributed to Inlyta. Relatedness to Inlyta was assessed by the physician. An unexpected AE was an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug. Unexpected ADRs were unexpected AEs that were, in the investigator's opinion, of causal relationship to the study treatment."}, {'measure': 'Duration of Adverse Events', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)"}, {'measure': 'Number of Participants With Adverse Events by Their Severity', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Severity was graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 where, Grade 1: mild; Grade 2: moderate; Grade 3:severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. One participant may experience more than one event hence, one participant may be included in more than one category specified below.'}, {'measure': 'Number of Participants With Adverse Events by Their Outcome', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The outcomes of AE included recovered, recovered with sequelae, recovering, not recovered and unknown. One participant may experience more than one event hence one participant may be included in more than one category specified below.'}, {'measure': 'Number of Participants With Adverse Events by Their Seriousness Criteria', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The seriousness criteria for AEs included results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect, other important medical event.'}, {'measure': 'Number of Participants With Adverse Events by Their Causality to Inlyta', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship. The causality of AEs to Inlyta were assessed by physician according to the following criteria: certain, probable/likely, possible, unlikely, conditional/unclassified and unaccessible/unclassifiable. One participant may experience more than one event hence, one participant may be included in more than one category specified below.'}, {'measure': 'Number of Participants With Adverse Events by Their Other Causality', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. If the AEs were not related to Inlyta, physicians were required to indicate the most appropriate cause of AEs from the following: disease under the study, other disease, concomitant treatment drug or non-drug and others.'}, {'measure': 'Number of Participants With Adverse Events by Their Action Taken With Study Drug', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The action taken with study drug due to AEs included discontinuation, dosage reduced, no change, unknown and not applicable. One participant may experience more than one event hence, one participant may be included in more than one category specified below.'}, {'measure': 'Number of Participants With Adverse Events According to Demographic Characteristics', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Number of participants with AEs classified according to the following demographic characteristics: sex: male and female; age: less than (\\<) 60 years, greater than or equal to (\\>=) 60 and \\< 70 years and \\>= 70 years; pediatric (\\<19 years); geriatric (\\>=65 years); classification: outpatient and inpatient were reported in the outcome measure.'}, {'measure': 'Number of Participants With Adverse Events According to Other Baseline Characteristics', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Number of participants with AEs classified according to the following characteristics: duration of aRCC: \\< 30 months, \\>= 30 months and \\< 60 months,\\>= 60 months; cell component of aRCC : clear cell ,other; metastasis: yes,no; site of metastasis: liver, lung, bone, brain, skin, lymph nodes, other; primary lesion surgery: done and not done; medical history: yes and no; renal impairment: yes and no; hepatic impairment: yes and no; allergic history: yes and no; prior chemotherapy: yes and no; prior immunotherapy: yes and no; prior radiation therapy: yes and no; concomitant medication: yes and no; duration of administration: \\< 90 days, \\>=90 and \\<180 days and \\>= 180 days; daily average dose: \\<10 and \\>=10 milligrams per day (mg/day).'}, {'measure': 'Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage.'}, {'measure': 'Number of Participants With AEs and ADRs - Special Participant Population', 'timeFrame': "From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)", 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Inlyta in a participant who received Inlyta.'}, {'measure': 'Number of Participants With Tumor Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1', 'timeFrame': 'From first dose of Inlyta up to first documented CR, PR, PD or SD, during observation period of the study of 9 years', 'description': 'Tumor response based on RECIST 1.1 was defined as: complete response (CR): complete disappearance of all target and non-target lesions. All lymph nodes must be non-pathological in size (\\<10 mm short axis); partial response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered a sign of progression; stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study and not done.'}, {'measure': 'Number of Participants With Objective Response', 'timeFrame': 'From first dose of Inlyta up to first documented CR or PR, during observation period of the study of 9 years', 'description': 'Objective response (OR) was defined as the achievement of partial or complete response to therapy based on RECIST 1.1. CR: complete disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\\<10 mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.'}, {'measure': 'Number of Participants With Objective Response According to Demographic Characteristics', 'timeFrame': 'From first dose of Inlyta up to first documented CR or PR, during observation period of the study of 9 years', 'description': 'OR was defined as the number of participants who have a partial or complete response to therapy. CR: complete disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\\<10 mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Number of participants with objective response categorized according to the following demographic characteristics was presented in this outcome measure: sex: male and female; age: \\< 60 years, \\>= 60 and \\< 70 years, \\>= 70 years; pediatric (\\<19 years); geriatric (\\>=65 years); classification: outpatient and inpatient.'}, {'measure': 'Number of Participants With Objective Response According to Other Baseline Characteristics', 'timeFrame': 'From first dose of Inlyta up to first documented CR or PR, during observation period of the study of 9 years', 'description': 'OR was defined as the number of participants who have a partial or complete response to therapy. Number of participants with OR classified according to the following characteristics included duration of aRCC: \\< 30 months, \\>= 30 months and \\< 60 months and \\>= 60 months; cell component of aRCC : clear cell and other; metastasis: yes and no; site of metastasis: liver, lung, bone, brain, skin, lymph nodes and other; primary lesion surgery: done and not done; medical history: yes and no; renal impairment: yes and no; hepatic impairment: yes and no; allergic history: yes and no; prior chemotherapy: yes and no; prior immunotherapy: yes and no; prior radiation therapy: yes and no; concomitant medication: yes and no; duration of administration: \\< 90 days, \\>=90 and \\<180 days and \\>= 180 days; daily average dose: \\<10 and \\>=10 mg/day.'}, {'measure': 'Number of Participants With Objective Response - Multivariate Logistic Regression Analysis', 'timeFrame': 'From first dose of Inlyta up to first documented CR or PR, during observation period of the study of 9 years', 'description': 'OR was defined as the achievement of partial or complete response to therapy based on RECIST 1.1. CR: complete disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\\<10 mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From first dose of Inlyta up to first documented tumor progression or death, whichever occurred first, during observation period of the study of 9 years', 'description': 'PFS was defined as the time from first dose of Inlyta to first documentation of objective tumor progression, or to death due to any cause, whichever occurred first. Tumor progression was determined from tumor assessment criteria(where data meet the criteria for progressive disease \\[PD\\]), or from death report on case report forms (CRFs). PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered a sign of progression.'}, {'measure': 'Time to Progression (TTP)', 'timeFrame': 'From first dose of Inlyta up to first documented disease progression or latest follow-up, during observation period of the study of 9 years', 'description': 'TTP was defined as the time from the start of Inlyta treatment to date of disease progression. If there was no progression, the case was censored as TTP at latest follow-up. Disease progression was defined as \\>20% increase in sum of longest diameter of target lesions compared to baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Korean PMS of Axitinib', 'Metastatic RCC ; 2nd line only'], 'conditions': ['Advanced Renal Cell Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=A4061075', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to monitor the usage of INLYTA® in real practice, including the adverse events associated with INLYTA®.', 'detailedDescription': 'Investigators can choose any patient who is within the scope of I/E criteria'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Korea who has a disease for which Axitinib is indicated', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed as advanced RCC after failure of one prior systemic therapy.\n\nExclusion Criteria:\n\n* Any patient who does not agree that Pfizer or companies working on behalf of Pfizer can use his/her information.\n* Patients with hypersensitivity to axitinib or to any other component of INLYTA® .\n* Patients under 18.\n* Pregnant women.'}, 'identificationModule': {'nctId': 'NCT02156895', 'briefTitle': 'Post Marketing Surveillance Study to Observe Safety and Efficacy of Inlyta in South Korea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'POST MARKETING SURVEILLANCE STUDY TO OBSERVE SAFETY AND EFFICACY OF INLYTA (REGISTERED)', 'orgStudyIdInfo': {'id': 'A4061075'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who are using Axitinib', 'interventionNames': ['Drug: Axitinib']}], 'interventions': [{'name': 'Axitinib', 'type': 'DRUG', 'description': 'based on Axitinib approval', 'armGroupLabels': ['Patients who are using Axitinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04631', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pfizer Tower', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}