Viewing Study NCT01367457

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Ignite Creation Date: 2025-12-24 @ 6:58 PM
Ignite Modification Date: 2026-02-27 @ 8:27 AM
Study NCT ID: NCT01367457
Status: COMPLETED
Last Update Posted: 2016-04-27
First Post: 2011-06-03
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: INHIBITOR: Retrospective Study Of Patients With Renal Cell Carcinoma And Mantle Cell Lymphoma Treated With Temsirolimus
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-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'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C401859', 'term': 'temsirolimus'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'phoneExt': '001', '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': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'RCC: Temsirolimus', 'description': 'Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.', 'otherNumAtRisk': 193, 'otherNumAffected': 142, 'seriousNumAtRisk': 193, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'MCL: Temsirolimus', 'description': 'Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.', 'otherNumAtRisk': 23, 'otherNumAffected': 18, 'seriousNumAtRisk': 23, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'MCL: Temsirolimus + Rituximab', 'description': 'Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.', 'otherNumAtRisk': 26, 'otherNumAffected': 14, 'seriousNumAtRisk': 26, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Hypermagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Hypertriglyceridemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Bone marrow toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Skin toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Dermal toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Nail toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Skin mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Tonsillar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Gastrointestinal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 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1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Eyelids pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 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'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Others', 'notes': 'No coding was available in MedDRA dictionary for this event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Gastrointestinal toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Haemangioblastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Others', 'notes': 'No coding was available in MedDRA dictionary for this event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'no coding dictionary'}, {'term': 'Aspergillus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RCC: Temsirolimus', 'description': 'Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.'}, {'id': 'OG001', 'title': 'MCL: Temsirolimus', 'description': 'Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.'}, {'id': 'OG002', 'title': 'MCC: Temsirolimus + Rituximab', 'description': 'Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.04', 'groupId': 'OG000', 'lowerLimit': '3.03', 'upperLimit': '5.05'}, {'value': '7.467', 'groupId': 'OG001', 'lowerLimit': '4.171', 'upperLimit': '10.763'}, {'value': '13.233', 'groupId': 'OG002', 'lowerLimit': '3.306', 'upperLimit': '23.161'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From initiation of treatment up to disease progression (up to 80 months)', 'description': 'Progression-free survival: interval between start of treatment to first day when progressive disease (PD) was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) for participants with RCC and Cheson criteria for participants with MCL, or death due to any cause. RECIST criteria: at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Appearance of one or more new lesions also considered progression. Cheson criteria: appearance of any new sites of lymphoma OR at least 50% increase in product of longest perpendicular dimensions of any previously identified lymph node mass (LNM) OR at least 50% increase in longest dimension of any previously identified LNM greater than 1 cm in longest transverse dimension OR at least 50% increase in size of any previously involved site of lymphoma.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RCC: Temsirolimus', 'description': 'Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.'}, {'id': 'OG001', 'title': 'MCL: Temsirolimus', 'description': 'Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.'}, {'id': 'OG002', 'title': 'MCC: Temsirolimus + Rituximab', 'description': 'Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '34.8', 'groupId': 'OG001'}, {'value': '30.8', 'groupId': 'OG002'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '17.4', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '46.6', 'groupId': 'OG000'}, {'value': '26.1', 'groupId': 'OG001'}, {'value': '7.7', 'groupId': 'OG002'}]}]}, {'title': 'DP', 'categories': [{'measurements': [{'value': '38.6', 'groupId': 'OG000'}, {'value': '21.7', 'groupId': 'OG001'}, {'value': '11.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From initiation of treatment up to disease progression (up to 80 months)', 'description': 'Objective response: percentage of participants who achieved complete remission (CR) or partial response (PR). RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. RECIST criteria (CR: disappearance of all target lesions, any pathological lymph nodes(target or non-target) reduced in short axis to \\<10 mm, PR: at least 30% decrease in sum of diameters of target lesions). Cheson criteria (CR: all lymph node masses regressed to normal size, each lymph node mass that was \\>1.5 cm in longest transverse dimension regressed to \\<=1.5 cm, lymph node mass that was 1.1-1.5 cm regressed to \\<=1 cm, complete disappearance of all radiographic evidence of disease, PR: at least 50% decrease in sum of products of the longest perpendicular dimensions of the previously identified dominant lymph node masses, no increase in size of other lymph nodes.)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RCC: Temsirolimus', 'description': 'Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.'}, {'id': 'OG001', 'title': 'MCL: Temsirolimus', 'description': 'Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.'}, {'id': 'OG002', 'title': 'MCC: Temsirolimus + Rituximab', 'description': 'Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.21', 'groupId': 'OG000', 'lowerLimit': '8.55', 'upperLimit': '17.87'}, {'value': '7.28', 'groupId': 'OG001', 'lowerLimit': '4.23', 'upperLimit': '9.85'}, {'value': '8.82', 'groupId': 'OG002', 'lowerLimit': '6.42', 'upperLimit': '13.16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From initiation of treatment up to disease progression (up to 80 months)', 'description': 'Duration of response (DOR) was defined as the interval from the date the response was documented to the first date that progression of disease (PD) was observed in participants with PR or CR. RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. PD, CR and PR are defined in primary outcome 1 and 2.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RCC: Temsirolimus', 'description': 'Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.'}, {'id': 'OG001', 'title': 'MCL: Temsirolimus', 'description': 'Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.'}, {'id': 'OG002', 'title': 'MCC: Temsirolimus + Rituximab', 'description': 'Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.81', 'groupId': 'OG000', 'lowerLimit': '8.20', 'upperLimit': '13.42'}, {'value': '19.233', 'groupId': 'OG001', 'lowerLimit': '3.052', 'upperLimit': '35.415'}, {'value': '18.667', 'comment': 'The last event had happened when function survival reached the median value.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From initiation of treatment untill death (up to 80 months)', 'description': 'Overall survival (OS) was defined as the interval from the day of the start of the treatment to death, or censored to the last date when the participant was identified to be alive.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RCC: Temsirolimus', 'description': 'Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.'}, {'id': 'OG001', 'title': 'MCL: Temsirolimus', 'description': 'Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.'}, {'id': 'OG002', 'title': 'MCC: Temsirolimus + Rituximab', 'description': 'Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to the 28 calendar days after the last administration of study drug (upto 80 months)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events (Non-SAEs).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants with RCC or MCL who received atleast 1 dose of study treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RCC: Temsirolimus', 'description': 'Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.'}, {'id': 'FG001', 'title': 'MCL: Temsirolimus', 'description': 'Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.'}, {'id': 'FG002', 'title': 'MCL: Temsirolimus + Rituximab', 'description': 'Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': "Investigator's decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Clinical decline (CD)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Progression and death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Patient asks for rest + slow progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': "Investigator's opinion, stable disease", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Bleeding from cavernous haemangioma', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': '3 yr Temsirolimus treatment (no disease)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'low grade toxicities + stable disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Choledocolithiasis and pancreatitis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'CD, associated leukaemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Uncontrolled pain', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Overall status worsens to grade 4', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Stabilisation + frequent infections', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'No clinical benefit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Intestinal obstruction with necrosis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Overall decline', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Rejection of treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death from septic shock', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'CD, Suspected disease progression (DP)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': "Patient's Wish", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Palliative. Overall decline', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Suspected DP/suspected active infection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 243 participants were enrolled in the study, out of which 242 participants received treatment in reporting group "RCC: Temsirolimus", "MCL: Temsirolimus" or "MCL: Temsirolimus + Rituximab"'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '242', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'RCC: Temsirolimus', 'description': 'Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.'}, {'id': 'BG001', 'title': 'MCL: Temsirolimus', 'description': 'Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.'}, {'id': 'BG002', 'title': 'MCL: Temsirolimus + Rituximab', 'description': 'Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.27', 'spread': '11.14', 'groupId': 'BG000'}, {'value': '70.56', 'spread': '11.07', 'groupId': 'BG001'}, {'value': '72.34', 'spread': '7.11', 'groupId': 'BG002'}, {'value': '66.54', 'spread': '11.04', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline population included all participants with RCC or MCL who received atleast 1 dose of study treatment.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 243}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-25', 'studyFirstSubmitDate': '2011-06-03', 'resultsFirstSubmitDate': '2016-03-25', 'studyFirstSubmitQcDate': '2011-06-06', 'lastUpdatePostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-25', 'studyFirstPostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'From initiation of treatment up to disease progression (up to 80 months)', 'description': 'Progression-free survival: interval between start of treatment to first day when progressive disease (PD) was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) for participants with RCC and Cheson criteria for participants with MCL, or death due to any cause. RECIST criteria: at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Appearance of one or more new lesions also considered progression. Cheson criteria: appearance of any new sites of lymphoma OR at least 50% increase in product of longest perpendicular dimensions of any previously identified lymph node mass (LNM) OR at least 50% increase in longest dimension of any previously identified LNM greater than 1 cm in longest transverse dimension OR at least 50% increase in size of any previously involved site of lymphoma.'}, {'measure': 'Percentage of Participants With Objective Response', 'timeFrame': 'From initiation of treatment up to disease progression (up to 80 months)', 'description': 'Objective response: percentage of participants who achieved complete remission (CR) or partial response (PR). RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. RECIST criteria (CR: disappearance of all target lesions, any pathological lymph nodes(target or non-target) reduced in short axis to \\<10 mm, PR: at least 30% decrease in sum of diameters of target lesions). Cheson criteria (CR: all lymph node masses regressed to normal size, each lymph node mass that was \\>1.5 cm in longest transverse dimension regressed to \\<=1.5 cm, lymph node mass that was 1.1-1.5 cm regressed to \\<=1 cm, complete disappearance of all radiographic evidence of disease, PR: at least 50% decrease in sum of products of the longest perpendicular dimensions of the previously identified dominant lymph node masses, no increase in size of other lymph nodes.)'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'From initiation of treatment up to disease progression (up to 80 months)', 'description': 'Duration of response (DOR) was defined as the interval from the date the response was documented to the first date that progression of disease (PD) was observed in participants with PR or CR. RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. PD, CR and PR are defined in primary outcome 1 and 2.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From initiation of treatment untill death (up to 80 months)', 'description': 'Overall survival (OS) was defined as the interval from the day of the start of the treatment to death, or censored to the last date when the participant was identified to be alive.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline to the 28 calendar days after the last administration of study drug (upto 80 months)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events (Non-SAEs).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Carcinoma, Renal Cell', 'Lymphoma, Mantle-Cell']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1771017&StudyName=INHIBITOR%3A%20Retrospective%20Study%20Of%20Patients%20With%20Renal%20Cell%20Carcinoma%20And%20Mantle%20Cell%20Lymphoma%20Treated%20With%20Temsirolimus', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The principal objective of the study is to evaluate the efficacy and safety of temsirolimus use in patients with Renal Cell Carcinoma and Mantle Cell Lymphoma.', 'detailedDescription': 'There is not sampling method'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice.\n\nExclusion Criteria:\n\nPatients that do not have a minimum (pre-specified) of data in their clinical record.'}, 'identificationModule': {'nctId': 'NCT01367457', 'briefTitle': 'INHIBITOR: Retrospective Study Of Patients With Renal Cell Carcinoma And Mantle Cell Lymphoma Treated With Temsirolimus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Inhibitor - Estudio Retrospectivo De Casos Clinicos De Pacientes Con Carcinoma De Celulas Renales Y Con Linforma De Celulas Del Manto Tratados Con Temsirolimus', 'orgStudyIdInfo': {'id': 'B1771017'}, 'secondaryIdInfos': [{'id': 'INHIBITOR', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients that received treatment with Temsirolimus', 'description': 'Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice.', 'interventionNames': ['Other: Temsirolimus (Non-Interventional Study)']}], 'interventions': [{'name': 'Temsirolimus (Non-Interventional Study)', 'type': 'OTHER', 'description': 'There is not any intervention in this study.', 'armGroupLabels': ['Patients that received treatment with Temsirolimus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15006', 'city': 'A Coruña', 'state': 'A Coruña', 'country': 'Spain', 'facility': 'Complexo Hospitalario Universitario A Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '08025', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de La Santa Creu I Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall D'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8940', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '33394', 'city': 'Cabueñes', 'state': 'Gijon', 'country': 'Spain', 'facility': 'Hospital de Cabueñes', 'geoPoint': {'lat': 43.52347, 'lon': -5.60569}}, {'zip': '15006', 'city': 'A Coruña', 'state': 'La Coruña', 'country': 'Spain', 'facility': 'Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'La Coruña', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '35016', 'city': 'Las Palmas de Gran Canaria', 'state': 'Las Palmas', 'country': 'Spain', 'facility': 'Complejo Hospitalario Materno-Infantil Insular de Las Palmas', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'zip': '28007', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marañon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital de Madrid Norte - Sanchinarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Hospital de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '33006', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'Hospital Universitario Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '12002', 'city': 'Castellon', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Provincial de Castellon', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}, {'zip': '05004', 'city': 'Ávila', 'country': 'Spain', 'facility': 'Complejo AAsistencial de Avilla', 'geoPoint': {'lat': 40.65724, 'lon': -4.69951}}, {'zip': '28033', 'city': 'Madrid', 'country': 'Spain', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}