Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-02-25 @ 6:57 PM
Study NCT ID:
NCT03916458
Status:
COMPLETED
Last Update Posted:
2021-12-13
First Post:
2019-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
REGISTRY OF COMPLETE RESPONSES TO SUNITINIB IN SPANISH PATIENTS WITH METASTATIC RENAL CELL CARCINOMA
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, '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': 'Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'description': 'Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Sunitinib', 'description': 'Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 51, 'seriousNumAtRisk': 62, 'deathsNumAffected': 2, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Cardiotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 10}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Gastrointestinal toxicity NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Skin bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Fluid retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Hyertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Nephrotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Albinism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Hair colour changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Nail pigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Onycholysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 25}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Skin discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Skin reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Skin toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Xeroderma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Yellow skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 20}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Salmonelosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Complete Remission of Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib', 'description': 'Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.'}], 'classes': [{'title': 'CR at 1st CT Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '63.2'}]}]}, {'title': 'CR at 2nd CT Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '67.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'description': 'Time to complete remission of lesions was calculated as the difference between treatment start date and complete response (CR) confirmation date. As per response evaluation criteria in solid tumors (RECIST) version (v) 1.1, CR = disappearance of all known target and all non-target lesions and the absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10 millimeter (mm). CR was confirmed with 2 consecutive computed tomography (CT) scans performed with at least 4 weeks between them during the follow-up of participants. Confirmation from the oncologist and radiologist was required at each site.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. This outcome measure was evaluated in participants who achieved CR at respective CT scans.'}, {'type': 'PRIMARY', 'title': 'Duration of Complete Remission (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib', 'description': 'Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.'}], 'classes': [{'title': 'DOR, 1st CT Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.1', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '145.2'}]}]}, {'title': 'DOR, 2nd CT Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '62.2', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '142.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first documented CR date until progression/death or change of treatment due to unacceptable toxicity or last follow-up date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'description': 'DOR was defined as the time from date on which the CR was identified until tumor progression, the change of treatment due to unacceptable toxicity, death from any cause or until the date of the last follow-up at the close of study. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10 mm. Tumor progression = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of \\>=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. This outcome measure was evaluated in participants who achieved CR at respective CT scans.'}, {'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib', 'description': 'Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and full range could not be estimated because there were insufficient number of participants with event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From CR confirmation date until progression/death or change of treatment due to unacceptable toxicity/last follow-up date, up to maximum of approximately 13 years (data collected, observed retrospectively for approximately 10 months)', 'description': 'PFS was calculated as the time from the date of CR confirmation (2nd CT scan) until the date of progression/death or change of treatment for unacceptable toxicity or censored on the date of the last follow-up. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10 mm. Tumor progression = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of \\>=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Analysis was performed using Kaplan-Meier method.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to Achieve CR in Participants Classified According to Heng I Criteria Prognosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib', 'description': 'Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.'}], 'classes': [{'title': 'Favorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '31.8'}]}]}, {'title': 'Intermediate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '63.2'}]}]}, {'title': 'Poor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '13.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'description': 'Time to CR: difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site. Heng prognostic model identified KPS of \\<80 at treatment initiation, period from diagnosis to start of treatment for metastatic disease \\<1year, anemia, hypercalcemia, neutrophilia, thrombocytosis as prognostic factors. Participants were classified into 3 prognosis group: favorable(0 factor), intermediate(1-2 factors) and poor(3 or more factors). KPS measured ability of participants with cancer to perform ordinary tasks. KPS scores range: 0 (dead) to 100 (normal, no complaint). High KPS score= participant better able to carry out daily activities.', 'unitOfMeasure': 'Month', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. Here "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to Achieve CR in Participants Classified According to Heng I Criteria Prognosis at Least 2 Consecutive CT Scans', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib', 'description': 'Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.'}], 'classes': [{'title': 'Favorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '37.0'}]}]}, {'title': 'Intermediate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '67.2'}]}]}, {'title': 'Poor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '17.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'description': 'Time to CR: difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site. Heng prognostic model identified KPS of \\<80 at treatment initiation, period from diagnosis to start of treatment for metastatic disease \\<1year, anemia, hypercalcemia, neutrophilia, thrombocytosis as prognostic factors. Participants were classified into 3 prognosis group: favorable(0 factor), intermediate(1-2 factors) and poor(3 or more factors). KPS measured ability of participants with cancer to perform ordinary tasks. KPS scores range: 0(dead) to 100(normal, no complaint). High KPS score=participant better able to carry out daily activities.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. Here "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to Achieve CR in Participants Classified According to Previous Nephrectomy Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib', 'description': 'Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.'}], 'classes': [{'title': 'Previous Nephrectomy: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '47.2'}]}]}, {'title': 'Previous Nephrectomy: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '63.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'description': 'Time to achieve CR according to previous nephrectomy status were reported in this outcome measure. Time to CR was calculated as the difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to Achieve CR in Participants Classified According to Histology Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib', 'description': 'Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.'}], 'classes': [{'title': 'Clear cell', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '63.2'}]}]}, {'title': 'Non-clear cell', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '18.3'}]}]}, {'title': 'Sarcomatoid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '47.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'description': 'Time to achieve CR according to type of histology as clear cell, non-clear cell and sarcomatoid were reported in this outcome measure. Time to CR was calculated as the difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. Here "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Duration of Response Based on Type of Treatment Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib', 'description': 'Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.'}], 'classes': [{'title': 'Sunitinib Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '69.8', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '145.2'}]}]}, {'title': 'Sunitinib + subsequent local treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58.4', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '110.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first documented CR date until progression/death or change of treatment due to unacceptable toxicity or last follow-up date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'description': 'Duration of response was defined as the time from date on which the CR was identified until the date of the CT scan conforming tumor progression, the change of treatment due to unacceptable toxicity, death from any cause or until the date of the last follow-up at the close of study. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10 mm. Tumor progression = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of \\>=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Analysis was performed using Kaplan-Meier method.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. Here, "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Dose Interruption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib', 'description': 'Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Who Received Subsequent Local Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib', 'description': 'Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'description': 'Local treatments were the following: traditional surgery, radiotherapy, or stereotactic body radiation therapy (SBRT), to achieve the total macroscopic disappearance of the disease along with CR, according to the opinion of the physician responsible for the participant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Who Discontinued Sunitinib Treatment Due to Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib', 'description': 'Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'description': 'Number of participants who discontinued sunitinib treatment due to toxicity were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. Here "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Grade 3 or Higher Toxicity to Sunitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib', 'description': 'Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'description': 'Number of participants with Grade 3 or higher toxicity as per common terminology criteria for adverse events (CTCAE) version 4 were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. Here "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sunitinib', 'description': 'Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 milligrams (mg) capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Out of these 62 participants, 2 participants died. But data available before censoring date for these 2 participants were observed and included in results.', 'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants aged above or equal to 18 years, with metastatic renal cell carcinoma (mRCC), and who according to the usual evaluation criteria in daily clinical practice obtained a complete response with sunitinib as first-line treatment between 2007 and 30 October 2018, either alone or with subsequent local treatment, were observed retrospectively in this study for a period of 10 months approximately.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sunitinib', 'description': 'Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '58.3', 'spread': '11.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female'}, {'title': 'Male'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Gender data was never collected.'}, {'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': 'Number of Participants With Comorbidities', 'classes': [{'title': 'Cardiovascular Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}, {'title': 'Liver Disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Renal Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Autoimmune Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Chronic Dermatological Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Obesity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Bowel Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Other Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Comorbidities at baseline included cardiovascular disease, liver disorders, renal failure, autoimmune disease, chronic dermatological disease, obesity, bowel disease and other disease. One participant might have more than 1 comorbidity.', 'unitOfMeasure': 'Participants'}, {'title': 'Participants With Number of Metastatic Sites', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'title': '1', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': '2', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': '3', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '4', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '5', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Greater than (>) 5', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Data not available', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Here, number of participants were classified according to number of metastatic sites.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants According to Type of Metastatic Sites', 'classes': [{'title': 'Lung', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}, {'title': 'Liver', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Brain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Pancreas', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Contralateral Kidney', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Nodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'Bone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Muscles, Soft tissues, Vessels and Peritoneum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Endocrine Glands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Here, number of participants were classified according to type of metastatic sites. One participant might have more than metastatic sites.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants Classified According to Tumor Fuhrman Grade', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'title': 'I', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'II', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'III', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'IV', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'II and IV', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Data not available', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The four-tiered Fuhrman grading evaluates nuclear size, nuclear shape and presence of nucleolar prominence. Grade I - small (=10 micrometer \\[mcm\\]) nuclear diameter, round/uniform nuclear shape and absent/inconspicuous nucleoli; Grade II - large (=15 mcm) nuclear diameter, irregular outline nuclear shape and visible at \\*400 magnification nucleoli; Grade III - Larger (=20 mcm) nuclear diameter, obvious irregular outline nuclear shape and visible and prominent at \\*100 magnification nucleoli; Grade IV - grade 3 plus bizarre multilobed nuclei +/- spindle cells.', 'unitOfMeasure': 'Participants'}, {'title': 'Histological Type of Tumor', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Clear Cell', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}, {'title': 'Non-clear Cell', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Sarcomatoid', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Data not available', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Here, number of participants were classified according to type of histology as clear cell, non-clear cell and sarcomatoid.', 'unitOfMeasure': 'Participants'}, {'title': 'Pre-treatment Necrosis Percentage', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18.2', 'spread': '30.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage of Necrosis', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Here, number analyzed signifies participants evaluable for this baseline measure.'}, {'title': 'Number of Participants With Previous Nephrectomy Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '56', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Here, number of participants were classified according to presence of previous nephrectomy as Yes or No.', 'unitOfMeasure': 'Participants'}, {'title': 'Time Interval From Nephrectomy to Initiation of Sunitinib Treatment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'BG000', 'lowerLimit': '0.5', 'upperLimit': '174.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Months', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Here, number analyzed signifies participants evaluable for this baseline measure.'}, {'title': 'Number of Participants Classified According to Motzer Prognostic Criteria', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Favorable', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Intermediate', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Poor', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Motzer prognostic model identified karnofsky performance status(KPS) less than (\\<)80 at treatment initiation, period from diagnosis to start of treatment for metastatic disease \\<1 year, anemia, hypercalcemia, elevated lactate dehydrogenase as prognostic factors. Participants were classified into prognosis group: favorable(0 factor), intermediate(1-2 factors), poor(3 or more factors). KPS measured ability of participants with cancer to perform ordinary tasks. KPS scores range: 0 (dead) to 100 (normal, no complaint). High score= participant better able to carry out daily activities.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Here, number analyzed signifies participants evaluable for this baseline measure.'}, {'title': 'Eastern Cooperative Oncology Group Performance Status (ECOG PS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': '1', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Data not available', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ECOG PS: measure quality of life of cancer participants on a 0 to 5 scale; 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity, ambulatory, able to carry out light/ sedentary work; 2= ambulatory, capable of all self-care, unable to carry out any work activity, up \\>50 % of waking hours; 3= capable of only limited self-care, confined to bed/ chair \\>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead.', 'unitOfMeasure': 'Participants'}, {'title': 'Blood Hemoglobin Level', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '14.0', 'spread': '3.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Gram per deciliter', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Here, number analyzed signifies participants evaluable for this baseline measure.'}, {'title': 'Corrected Blood Calcium Level', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9.4', 'spread': '0.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Milligram per deciliter', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Here, number analyzed signifies participants evaluable for this baseline measure.'}, {'title': 'Blood Lactate Dehydrogenase (LDH) Level', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '262.6', 'spread': '122.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Units per liter', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Here, number analyzed signifies participants evaluable for this baseline measure.'}, {'title': 'Platelets Level and Neutrophils Level', 'classes': [{'title': 'Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '260.0', 'spread': '99.6', 'groupId': 'BG000'}]}]}, {'title': 'Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '1.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '10^9 cells per liter', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Here, number analyzed signifies participants evaluable for this baseline measure.'}, {'title': 'Number of Participants Classified According to Heng Prognostic Criteria', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Favorable', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Intermediate', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'Poor', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Heng prognostic model identified KPS \\<80 at treatment initiation, period from diagnosis to start of treatment for metastatic disease \\<1 year, anemia, hypercalcemia, neutrophilia, thrombocytosis as prognostic factors. Participants classified into prognosis group: favorable (0 factor), intermediate (1-2 factors), poor (3 or more factors). KPS measured ability of participants with cancer to perform ordinary tasks. KPS scores range: 0= dead to 100= normal, no complaint. High score= participant better able to carry out daily activities.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Here, number analyzed signifies participants evaluable for this baseline measure.'}], 'populationDescription': 'Full analysis set (FAS) included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-18', 'size': 1019996, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-29T11:07', 'hasProtocol': True}, {'date': '2019-10-29', 'size': 772205, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-29T11:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-29', 'studyFirstSubmitDate': '2019-04-12', 'resultsFirstSubmitDate': '2021-10-29', 'studyFirstSubmitQcDate': '2019-04-12', 'lastUpdatePostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-29', 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to Achieve CR in Participants Classified According to Heng I Criteria Prognosis', 'timeFrame': 'From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'description': 'Time to CR: difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site. Heng prognostic model identified KPS of \\<80 at treatment initiation, period from diagnosis to start of treatment for metastatic disease \\<1year, anemia, hypercalcemia, neutrophilia, thrombocytosis as prognostic factors. Participants were classified into 3 prognosis group: favorable(0 factor), intermediate(1-2 factors) and poor(3 or more factors). KPS measured ability of participants with cancer to perform ordinary tasks. KPS scores range: 0 (dead) to 100 (normal, no complaint). High KPS score= participant better able to carry out daily activities.'}, {'measure': 'Time to Achieve CR in Participants Classified According to Heng I Criteria Prognosis at Least 2 Consecutive CT Scans', 'timeFrame': 'From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'description': 'Time to CR: difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site. Heng prognostic model identified KPS of \\<80 at treatment initiation, period from diagnosis to start of treatment for metastatic disease \\<1year, anemia, hypercalcemia, neutrophilia, thrombocytosis as prognostic factors. Participants were classified into 3 prognosis group: favorable(0 factor), intermediate(1-2 factors) and poor(3 or more factors). KPS measured ability of participants with cancer to perform ordinary tasks. KPS scores range: 0(dead) to 100(normal, no complaint). High KPS score=participant better able to carry out daily activities.'}, {'measure': 'Time to Achieve CR in Participants Classified According to Previous Nephrectomy Status', 'timeFrame': 'From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'description': 'Time to achieve CR according to previous nephrectomy status were reported in this outcome measure. Time to CR was calculated as the difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site.'}, {'measure': 'Time to Achieve CR in Participants Classified According to Histology Type', 'timeFrame': 'From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'description': 'Time to achieve CR according to type of histology as clear cell, non-clear cell and sarcomatoid were reported in this outcome measure. Time to CR was calculated as the difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site.'}, {'measure': 'Duration of Response Based on Type of Treatment Received', 'timeFrame': 'From first documented CR date until progression/death or change of treatment due to unacceptable toxicity or last follow-up date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'description': 'Duration of response was defined as the time from date on which the CR was identified until the date of the CT scan conforming tumor progression, the change of treatment due to unacceptable toxicity, death from any cause or until the date of the last follow-up at the close of study. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10 mm. Tumor progression = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of \\>=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Analysis was performed using Kaplan-Meier method.'}, {'measure': 'Number of Participants With Dose Interruption', 'timeFrame': 'From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)'}, {'measure': 'Number of Participants Who Received Subsequent Local Treatment', 'timeFrame': 'Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'description': 'Local treatments were the following: traditional surgery, radiotherapy, or stereotactic body radiation therapy (SBRT), to achieve the total macroscopic disappearance of the disease along with CR, according to the opinion of the physician responsible for the participant.'}, {'measure': 'Number of Participants Who Discontinued Sunitinib Treatment Due to Toxicity', 'timeFrame': 'From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'description': 'Number of participants who discontinued sunitinib treatment due to toxicity were reported in this outcome measure.'}, {'measure': 'Number of Participants With Grade 3 or Higher Toxicity to Sunitinib', 'timeFrame': 'From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'description': 'Number of participants with Grade 3 or higher toxicity as per common terminology criteria for adverse events (CTCAE) version 4 were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death.'}], 'primaryOutcomes': [{'measure': 'Time to Complete Remission of Lesions', 'timeFrame': 'From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'description': 'Time to complete remission of lesions was calculated as the difference between treatment start date and complete response (CR) confirmation date. As per response evaluation criteria in solid tumors (RECIST) version (v) 1.1, CR = disappearance of all known target and all non-target lesions and the absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10 millimeter (mm). CR was confirmed with 2 consecutive computed tomography (CT) scans performed with at least 4 weeks between them during the follow-up of participants. Confirmation from the oncologist and radiologist was required at each site.'}, {'measure': 'Duration of Complete Remission (DOR)', 'timeFrame': 'From first documented CR date until progression/death or change of treatment due to unacceptable toxicity or last follow-up date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)', 'description': 'DOR was defined as the time from date on which the CR was identified until tumor progression, the change of treatment due to unacceptable toxicity, death from any cause or until the date of the last follow-up at the close of study. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10 mm. Tumor progression = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of \\>=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From CR confirmation date until progression/death or change of treatment due to unacceptable toxicity/last follow-up date, up to maximum of approximately 13 years (data collected, observed retrospectively for approximately 10 months)', 'description': 'PFS was calculated as the time from the date of CR confirmation (2nd CT scan) until the date of progression/death or change of treatment for unacceptable toxicity or censored on the date of the last follow-up. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10 mm. Tumor progression = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of \\>=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Analysis was performed using Kaplan-Meier method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carcinoma, Renal Cell', 'Disease-Free Survival', 'Sunitinib', 'Protein Kinase Inhibitors', 'Angiogenesis Inhibitors', 'Prognosis'], 'conditions': ['Carcinoma, Renal Cell']}, 'referencesModule': {'references': [{'pmid': '36610891', 'type': 'DERIVED', 'citation': 'de Velasco G, Alonso-Gordoa T, Rodriguez-Vida A, Anguera G, Campayo M, Pinto A, Ortega EM, Gallardo E, Nunez NF, Garcia-Carbonero I, Reig O, Mendez-Vidal MJ, Fernandez-Calvo O, Cassinello NV, Torregrosa D, Lopez-Martin A, Rosero A, Valiente PG, de Espana CG, Climent MA, Santasusana MD, Sanchez AR, Gonzalez IC, Afonso R, Garcia Del Muro X, Casinello J, Fernandez-Parra EM, Garcia Sanchez L, Afonso J, Polo SH, Asensio U. Long-term Clinical Outcomes of a Spanish Cohort of Metastatic Renal Cell Carcinoma Patients with a Complete Response to Sunitinib. Clin Genitourin Cancer. 2023 Jun;21(3):e166-e174. doi: 10.1016/j.clgc.2022.11.021. Epub 2022 Dec 5.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=A6181227', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Observational, retrospective, multicentre study in spanish patients with metastatic Renal Cell Carcinoma (mRCC) treated with sunitinib as a first-line treatment (treatment with previous cytokine therapy is accepted) according to clinical practice who obtained a complete response (CR) to treatment in one of these 2 situations:\n\n1. Complete response (CR) obtained exclusively with first-line sunitinib treatment (sunitinib CR).\n2. Response obtained after a period of time on treatment with sunitinib in which local treatment was also performed (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) to achieve the total macroscopic disappearance of the disease, according to the opinion of the physician responsible for the patient (CR + local treatment).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patient population eligible for this study includes any patient with advanced or metastatic renal cell cancer who has been treated with Sunitinib and has achieved CR of the tumour and its metastases at any time during treatment and according to the usual assessment criteria in daily clinical practice, whether it was obtained with sunitinib alone or if a local treatment was needed to eradicate all the lesions: (surgery of the residual metastases, radiofrequency ablation or radiotherapy)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who are 18 year-old or over who have been treated for metastatic renal cell carcinoma with sunitinib as first-line treatment (treatment with prior cytokine therapy is accepted) between 2007 and 30 September 2018 and who have obtained as a best treatment response the total remission of the disease in the opinion of the doctor in charge from a clinical, radiological and/or macroscopic point of view. This response must have been reached through two possible strategies:\n\n A) Systemic treatment with sunitinib alone. B) Treatment with sunitinib and subsequent local treatment for one or more residual lesions that have not responded to the drug (traditional surgery, radiotherapy, SBRT (Stereotactic Body Radiation Therapy)).\n2. The duration of CR must have been confirmed with at least 2 consecutive imaging tests, without having a limit in the duration of this response. Although the patient had progressed subsequently, he/she may be included in this registry.\n3. Patients from any risk group\n4. Tumours of any histology\n\nExclusion Criteria:\n\n1. Patients treated with another drug other than Sunitinib.\n2. Patients with no radiology reports proving CR.\n3. Patients with no record of the dose and regimen received with Sunitinib.\n4. Patients who achieved complete remission after 30 September 2018.'}, 'identificationModule': {'nctId': 'NCT03916458', 'acronym': 'ATILA', 'briefTitle': 'REGISTRY OF COMPLETE RESPONSES TO SUNITINIB IN SPANISH PATIENTS WITH METASTATIC RENAL CELL CARCINOMA', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'REGISTRY OF COMPLETE RESPONSES TO SUNITINIB IN SPANISH PATIENTS WITH METASTATIC RENAL CELL CARCINOMA (ATILA STUDY)', 'orgStudyIdInfo': {'id': 'A6181227'}, 'secondaryIdInfos': [{'id': 'ATILA', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects with reported metastatic renal cell carcinoma', 'description': 'The subjects have been treatment with sunitinib and they reached complete remission'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08908', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Duran i Reynals', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '08243', 'city': 'Manresa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital San Juan de Dios', 'geoPoint': {'lat': 41.72815, 'lon': 1.82399}}, {'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Parc Taulí de Sabadell', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '08221', 'city': 'Terrassa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitario Mutua Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'facility': 'Hospital Universitario de Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '28922', 'city': 'Alcorcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Fundación Alcorcón', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}, {'zip': '28911', 'city': 'Leganés', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Severo Ochoa', 'geoPoint': {'lat': 40.32718, 'lon': -3.7635}}, {'zip': '28981', 'city': 'Parla', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Infanta Cristina', 'geoPoint': {'lat': 40.23604, 'lon': -3.76752}}, {'zip': '45004', 'city': 'Toledo', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospita Virgen de la Salud'}, {'zip': '07120', 'city': 'Palma de Mallorca', 'state': 'Mallorca', 'country': 'Spain', 'facility': 'Hospital Universitario Son Espases', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '38010', 'city': 'Santa Cruz de Tenerife', 'state': 'Tenerife', 'country': 'Spain', 'facility': 'Hospital Universitario Nuestra Señora de Candelaria', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'zip': '15011', 'city': 'A Coruña', 'country': 'Spain', 'facility': 'Complexo Hospitalario Universitario de Ferrol', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '06080', 'city': 'Badajoz', 'country': 'Spain', 'facility': 'Hospital Universitario Infanta Cristina', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08243', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínico de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Hospital Universitario Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '19002', 'city': 'Guadalajara', 'country': 'Spain', 'facility': 'Hospital Universitario de Guadalajara', 'geoPoint': {'lat': 40.62862, 'lon': -3.16185}}, {'zip': '23007', 'city': 'Jaén', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Jaén', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'zip': '24080', 'city': 'León', 'country': 'Spain', 'facility': 'Hospital Universitario de León', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'zip': '27003', 'city': 'Lugo', 'country': 'Spain', 'facility': 'Hospital Universitario Lucus Augusti / Servicio de Oncología Médica', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos de Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '32005', 'city': 'Ourense', 'country': 'Spain', 'facility': 'Complexo Hospitalario Universitario de Ourense', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}, {'zip': '40002', 'city': 'Segovia', 'country': 'Spain', 'facility': 'Complejo Asistencial de Segovia', 'geoPoint': {'lat': 40.94808, 'lon': -4.11839}}, {'zip': '41014', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital de Valme', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Instituto Valenciano de Oncología', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46017', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario Doctor Peset', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], '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'}}}}