Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT00700258
Status:
COMPLETED
Last Update Posted:
2024-09-23
First Post:
2008-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR]
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}, {'id': 'D000077210', 'term': 'Sunitinib'}, {'id': 'D000077784', 'term': 'Axitinib'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}]}}, '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': 'Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months', 'description': 'An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.', 'eventGroups': [{'id': 'EG000', 'title': 'mRCC - Temsirolimus', 'description': 'Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.', 'otherNumAtRisk': 605, 'deathsNumAtRisk': 605, 'otherNumAffected': 342, 'seriousNumAtRisk': 605, 'deathsNumAffected': 440, 'seriousNumAffected': 269}, {'id': 'EG001', 'title': 'mRCC - Sunitinib', 'description': 'Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.', 'otherNumAtRisk': 702, 'deathsNumAtRisk': 702, 'otherNumAffected': 485, 'seriousNumAtRisk': 702, 'deathsNumAffected': 420, 'seriousNumAffected': 284}, {'id': 'EG002', 'title': 'mRCC - Axitinib', 'description': 'Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.', 'otherNumAtRisk': 237, 'deathsNumAtRisk': 237, 'otherNumAffected': 148, 'seriousNumAtRisk': 237, 'deathsNumAffected': 163, 'seriousNumAffected': 111}, {'id': 'EG003', 'title': 'MCL - Temsirolimus', 'description': 'Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 45, 'seriousNumAtRisk': 59, 'deathsNumAffected': 40, 'seriousNumAffected': 26}, {'id': 'EG004', 'title': 'GIST - Sunitinib', 'description': 'Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 18, 'seriousNumAtRisk': 26, 'deathsNumAffected': 16, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 144}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Exercise tolerance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Chronic fatigue syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Drug intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Localised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Mucosal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Mucosal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Mucosal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Complication associated with device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Drug ineffective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 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{'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Concomitant disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'notes': 'Event was not coded by any medical dictionary and event was captured as Unknown.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Orthostatic intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Paraparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Posterior 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59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Retinal vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Hepatobiliary 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25.0'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hepatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Biliary obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cholangitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Autoimmune hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hepatorenal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Arthrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Central venous catheterisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nephrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Leg amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Adrenocortical insufficiency acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypercalcaemia of malignancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Inappropriate antidiuretic hormone secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hyperparathyroidism secondary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oedema genital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Uterine prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '577', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}, {'value': '221', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'mRCC - Temsirolimus', 'description': 'Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG001', 'title': 'mRCC - Sunitinib', 'description': 'Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG002', 'title': 'mRCC - Axitinib', 'description': 'Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG003', 'title': 'MCL - Temsirolimus', 'description': 'Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG004', 'title': 'GIST - Sunitinib', 'description': 'Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.04', 'groupId': 'OG000', 'lowerLimit': '9.56', 'upperLimit': '13.04'}, {'value': '25.36', 'groupId': 'OG001', 'lowerLimit': '22.18', 'upperLimit': '28.22'}, {'value': '18.37', 'groupId': 'OG002', 'lowerLimit': '14.03', 'upperLimit': '24.15'}, {'value': '15.11', 'groupId': 'OG003', 'lowerLimit': '8.54', 'upperLimit': '22.01'}, {'value': '16.30', 'groupId': 'OG004', 'lowerLimit': '7.29', 'upperLimit': '53.22'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months', 'description': 'OS was defined as the time from initiation of treatment to death from any cause. In case a death was documented, but date of death was unknown, the date of death was substituted with the latest available date for the participant (last visit, last contact date, date of assessment). If no death was documented, participant was censored with the latest available contact date or assessment date within study. If these rules led to a missing duration or a negative duration, duration was set to maximum of (PFS,"1 day"). Progression free survival (PFS) was defined as time from initiation of treatment to documented disease progression or death from any cause. progression was defined as the enlargement of the measured sum by 20% or one or more new lesions. This outcome measure was analyzed using Kaplan-Meier method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness analysis set (EAS): all participants included in study with at least 1 information on: date of death, progression, assessment of response to therapy by physician or assessment to either effectiveness or tolerability of therapy by physician. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.'}, {'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '577', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}, {'value': '221', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'mRCC - Temsirolimus', 'description': 'Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG001', 'title': 'mRCC - Sunitinib', 'description': 'Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG002', 'title': 'mRCC - Axitinib', 'description': 'Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG003', 'title': 'MCL - Temsirolimus', 'description': 'Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG004', 'title': 'GIST - Sunitinib', 'description': 'Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.91', 'groupId': 'OG000', 'lowerLimit': '3.45', 'upperLimit': '4.63'}, {'value': '6.93', 'groupId': 'OG001', 'lowerLimit': '6.24', 'upperLimit': '8.25'}, {'value': '5.75', 'groupId': 'OG002', 'lowerLimit': '4.90', 'upperLimit': '6.64'}, {'value': '3.68', 'groupId': 'OG003', 'lowerLimit': '3.02', 'upperLimit': '4.86'}, {'value': '10.32', 'groupId': 'OG004', 'lowerLimit': '3.58', 'upperLimit': '12.94'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months', 'description': 'PFS was defined as time from initiation of treatment to documented disease progression or death from any cause. The presence of a progression i.e. enlargement of the measured sum by 20% or one or more new lesions was confirmed, but (a) No date was documented: the date of last intake of study medication was used as date of progression, otherwise the date of the last visit with a documented "non-progression" was used as date of progression. (b) Dates within a visit and on final documentation were contradictory, the prior date was used. In case a death was documented within survival follow-up, but no progression was documented within regular study, the date of last visit plus 1 day was used as date of progression. In case no progression was documented, participant was censored with the latest available contact date or assessment date within study. In case these rules led to a missing duration or a negative duration, duration was set to "1 day". Kaplan-Meier method was used for analysis.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Best Overall Response (BOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '577', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}, {'value': '221', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'mRCC - Temsirolimus', 'description': 'Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG001', 'title': 'mRCC - Sunitinib', 'description': 'Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG002', 'title': 'mRCC - Axitinib', 'description': 'Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG003', 'title': 'MCL - Temsirolimus', 'description': 'Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG004', 'title': 'GIST - Sunitinib', 'description': 'Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'MR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '237', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'PD', 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Response could not be assessed', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months', 'description': 'BOR included Complete Remission (CR): complete disappearance of all lesions. Partial Remission (PR): Reduction of the measured total by at least 30%. Minor remission (MR): ≥10% decrease in the sum of longest diameters of target lesions but not a PR (\\<30%). Stable Disease (SD): neither shrinkage for CR/PR nor increase for progressive disease (PD) taking as reference smallest sum of longest diameters (SLDs) since treatment start. PD: Enlargement of the measured sum by 20% or one or more new lesions. In this outcome measure, number of participants with best overall response were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "EAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, 'Number Analyzed' signifies those participants who were evaluable for the specified rows."}, {'type': 'PRIMARY', 'title': "Number of Participants Categorized According to Physician's Global Assessment of Effectiveness", 'denoms': [{'units': 'Participants', 'counts': [{'value': '505', 'groupId': 'OG000'}, {'value': '575', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'mRCC - Temsirolimus', 'description': 'Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG001', 'title': 'mRCC - Sunitinib', 'description': 'Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG002', 'title': 'mRCC - Axitinib', 'description': 'Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG003', 'title': 'MCL - Temsirolimus', 'description': 'Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG004', 'title': 'GIST - Sunitinib', 'description': 'Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}], 'classes': [{'categories': [{'title': 'Very good', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Good', 'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}, {'title': 'Moderate', 'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}, {'title': 'Insufficient', 'measurements': [{'value': '159', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months', 'description': "In this outcome measure, number of participants were categorized according to physician's global assessment of effectiveness as very good, good, moderate, insufficient and missing. Categories were determined by investigator's discretion.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Karnofsky Performance Status (KPS) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}, {'value': '547', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'mRCC - Temsirolimus', 'description': 'Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG001', 'title': 'mRCC - Sunitinib', 'description': 'Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG002', 'title': 'mRCC - Axitinib', 'description': 'Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG003', 'title': 'GIST - Sunitinib', 'description': 'Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.9', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '78.8', 'spread': '14.1', 'groupId': 'OG001'}, {'value': '77.9', 'spread': '13.2', 'groupId': 'OG002'}, {'value': '77.8', 'spread': '8.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months', 'description': "Karnofsky performance score was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed for MCL.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status for Mantle Cell Lymphoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MCL - Temsirolimus', 'description': 'Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}], 'classes': [{'categories': [{'title': 'ECOG: 0', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'ECOG: 1', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'ECOG: 2', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months', 'description': "ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) 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/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, 2) and missing was evaluated for MCL as planned.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '605', 'groupId': 'OG000'}, {'value': '702', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'mRCC - Temsirolimus', 'description': 'Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG001', 'title': 'mRCC - Sunitinib', 'description': 'Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG002', 'title': 'mRCC - Axitinib', 'description': 'Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG003', 'title': 'MCL - Temsirolimus', 'description': 'Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG004', 'title': 'GIST - Sunitinib', 'description': 'Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '460', 'groupId': 'OG000'}, {'value': '585', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '269', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months', 'description': 'An adverse event (AE) was any undesirable medical event in a participant took a medicinal product. It was not necessarily required that the event is causally related to the treatment or use of the medicinal product. An SAE was any undesirable medical event that occurred in a participant received a medicinal product or dietary supplement (including infant formula) at any dose, and that resulted in death; was life-threatening; required an unforeseen hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial impairment of the ability to perform daily activities); resulted in a congenital malformation/birth defect. TEAEs were events between first dose of study drug and up to last documented follow-up visit that were absent before treatment or that worsened relative to pretreatment state. AEs included serious and all non-serious adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAS) comprised of all prospectively documented participants with histologically proven diagnosis of either mRCC, MCL or GIST and at least 1 documented administration of temsirolimus, sunitinib or axitinib or any non-Pfizer treatment. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Discontinued Treatment Due to Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '605', 'groupId': 'OG000'}, {'value': '702', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'mRCC - Temsirolimus', 'description': 'Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG001', 'title': 'mRCC - Sunitinib', 'description': 'Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG002', 'title': 'mRCC - Axitinib', 'description': 'Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG003', 'title': 'MCL - Temsirolimus', 'description': 'Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG004', 'title': 'GIST - Sunitinib', 'description': 'Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months', 'description': 'An AE was any undesirable medical event in a participant took a medicinal product. It was not necessarily required that the event is causally related to the treatment or use of the medicinal product. In this outcome measure number of participants who discontinued treatment due to adverse events were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.'}, {'type': 'PRIMARY', 'title': "Number of Participants Categorized According to Physician's Global Tolerability Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '505', 'groupId': 'OG000'}, {'value': '576', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'mRCC - Temsirolimus', 'description': 'Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG001', 'title': 'mRCC - Sunitinib', 'description': 'Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG002', 'title': 'mRCC - Axitinib', 'description': 'Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG003', 'title': 'MCL - Temsirolimus', 'description': 'Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG004', 'title': 'GIST - Sunitinib', 'description': 'Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}], 'classes': [{'categories': [{'title': 'Very good', 'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}, {'title': 'Good', 'measurements': [{'value': '306', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}, {'title': 'Moderate', 'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}, {'title': 'Insufficient', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months', 'description': "In this outcome measure, number of participants were categorized according to physician's global tolerability assessment as very good, good, moderate, insufficient and missing. Categories were determined by investigator's discretion.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'mRCC - Temsirolimus', 'description': 'Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG001', 'title': 'mRCC - Sunitinib', 'description': 'Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG002', 'title': 'mRCC - Axitinib', 'description': 'Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG003', 'title': 'MCL - Temsirolimus', 'description': 'Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG004', 'title': 'GIST - Sunitinib', 'description': 'Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}], 'classes': [{'title': 'Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '67.1', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '56.0', 'spread': '14.0', 'groupId': 'OG001'}, {'value': '64.4', 'spread': '10.8', 'groupId': 'OG002'}, {'value': '58.7', 'spread': '1.0', 'groupId': 'OG003'}, {'value': '58.7', 'spread': '13.7', 'groupId': 'OG004'}]}]}, {'title': 'Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '18.8', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '31.1', 'spread': '12.0', 'groupId': 'OG001'}, {'value': '23.7', 'spread': '9.1', 'groupId': 'OG002'}, {'value': '22.5', 'spread': '8.6', 'groupId': 'OG003'}, {'value': '28.9', 'spread': '12.6', 'groupId': 'OG004'}]}]}, {'title': 'Monocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8.9', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '2.3', 'groupId': 'OG002'}, {'value': '14.2', 'spread': '6.9', 'groupId': 'OG003'}, {'value': '8.8', 'spread': '2.9', 'groupId': 'OG004'}]}]}, {'title': 'Eosinophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '4.3', 'spread': '2.8', 'groupId': 'OG003'}, {'value': '2.1', 'spread': '2.5', 'groupId': 'OG004'}]}]}, {'title': 'Basophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '0.1', 'groupId': 'OG003'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG004'}]}]}, {'title': 'Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '33.8', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '37.0', 'spread': '5.2', 'groupId': 'OG001'}, {'value': '42.7', 'spread': '5.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 46 up to Week 55 post study inclusion', 'unitOfMeasure': 'Percentage of blood cells in blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure and \'Number Analyzed\' signifies those participants who were evaluable for the specified rows.'}, {'type': 'PRIMARY', 'title': 'Absolute Laboratory Values of Hematology Parameters: Hemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'mRCC - Temsirolimus', 'description': 'Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG001', 'title': 'mRCC - Sunitinib', 'description': 'Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG002', 'title': 'mRCC - Axitinib', 'description': 'Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG003', 'title': 'MCL - Temsirolimus', 'description': 'Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG004', 'title': 'GIST - Sunitinib', 'description': 'Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '7.5', 'spread': '3.2', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 46 up to Week 55 post study inclusion', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Here N=0 signifies that participants were not evaluable at the specified time point for HbA1c in MCL arm.'}, {'type': 'PRIMARY', 'title': 'Absolute Laboratory Values of Hematology Parameters: Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'mRCC - Temsirolimus', 'description': 'Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG001', 'title': 'mRCC - Sunitinib', 'description': 'Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG002', 'title': 'mRCC - Axitinib', 'description': 'Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG003', 'title': 'MCL - Temsirolimus', 'description': 'Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG004', 'title': 'GIST - Sunitinib', 'description': 'Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '14.4', 'spread': '1.7', 'groupId': 'OG002'}, {'value': '12.6', 'spread': '0.8', 'groupId': 'OG003'}, {'value': '11.9', 'spread': '1.2', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 46 up to Week 55 post study inclusion', 'unitOfMeasure': 'Grams per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'mRCC - Temsirolimus', 'description': 'Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG001', 'title': 'mRCC - Sunitinib', 'description': 'Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG002', 'title': 'mRCC - Axitinib', 'description': 'Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG003', 'title': 'MCL - Temsirolimus', 'description': 'Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG004', 'title': 'GIST - Sunitinib', 'description': 'Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}], 'classes': [{'title': 'Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '2.4', 'spread': '0.1', 'groupId': 'OG003'}, {'value': '2.3', 'spread': '0.1', 'groupId': 'OG004'}]}]}, {'title': 'Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '136.0', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '139.1', 'spread': '3.6', 'groupId': 'OG001'}, {'value': '138.1', 'spread': '4.0', 'groupId': 'OG002'}, {'value': '138.0', 'spread': 'NA', 'comment': 'Standard deviation was not calculated as only 1 participant was evaluable.', 'groupId': 'OG003'}, {'value': '139.0', 'spread': '2.7', 'groupId': 'OG004'}]}]}, {'title': 'Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '3.6', 'spread': '0.0', 'groupId': 'OG003'}, {'value': '4.1', 'spread': '0.9', 'groupId': 'OG004'}]}]}, {'title': 'Phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '0.9', 'spread': '0.2', 'groupId': 'OG004'}]}]}, {'title': 'Magnesium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '0.9', 'spread': 'NA', 'comment': 'Standard deviation was not calculated as only 1 participant was evaluable.', 'groupId': 'OG004'}]}]}, {'title': 'Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '6.6', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '5.9', 'spread': '2.1', 'groupId': 'OG004'}]}]}, {'title': 'Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '2.5', 'groupId': 'OG002'}, {'value': '5.2', 'spread': '3.4', 'groupId': 'OG004'}]}]}, {'title': 'Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '54.7', 'spread': '62.6', 'groupId': 'OG000'}, {'value': '39.4', 'spread': '52.4', 'groupId': 'OG001'}, {'value': '71.4', 'spread': '78.4', 'groupId': 'OG002'}, {'value': '77.2', 'spread': '143.2', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 46 up to Week 55 post study inclusion', 'unitOfMeasure': 'Millimoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure and \'Number Analyzed\' signifies those participants who were evaluable for the specified rows.'}, {'type': 'PRIMARY', 'title': 'Absolute Laboratory Values of Clinical Chemistry Parameters: Creatinine, Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'mRCC - Temsirolimus', 'description': 'Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG001', 'title': 'mRCC - Sunitinib', 'description': 'Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG002', 'title': 'mRCC - Axitinib', 'description': 'Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG003', 'title': 'MCL - Temsirolimus', 'description': 'Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG004', 'title': 'GIST - Sunitinib', 'description': 'Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}], 'classes': [{'title': 'Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '0.0', 'groupId': 'OG003'}, {'value': '1.1', 'spread': '0.3', 'groupId': 'OG004'}]}]}, {'title': 'Total bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '0.3', 'spread': 'NA', 'comment': 'Standard deviation was not calculated as only 1 participant was evaluable.', 'groupId': 'OG003'}, {'value': '0.4', 'spread': '0.1', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 46 up to Week 55 post study inclusion', 'unitOfMeasure': 'Milligrams per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure and \'Number Analyzed\' signifies those participants who were evaluable for the specified rows.'}, {'type': 'PRIMARY', 'title': 'Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'mRCC - Temsirolimus', 'description': 'Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG001', 'title': 'mRCC - Sunitinib', 'description': 'Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG002', 'title': 'mRCC - Axitinib', 'description': 'Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG003', 'title': 'MCL - Temsirolimus', 'description': 'Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG004', 'title': 'GIST - Sunitinib', 'description': 'Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}], 'classes': [{'title': 'ALT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20.2', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '25.9', 'spread': '17.5', 'groupId': 'OG001'}, {'value': '34.7', 'spread': '71.8', 'groupId': 'OG002'}, {'value': '24.0', 'spread': 'NA', 'comment': 'Standard deviation was not calculated as only 1 participant was evaluable.', 'groupId': 'OG003'}, {'value': '22.9', 'spread': '7.5', 'groupId': 'OG004'}]}]}, {'title': 'AST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '23.1', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '29.6', 'spread': '12.8', 'groupId': 'OG001'}, {'value': '44.3', 'spread': '84.3', 'groupId': 'OG002'}, {'value': '28.0', 'spread': 'NA', 'comment': 'Standard deviation was not calculated as only 1 participant was evaluable.', 'groupId': 'OG003'}, {'value': '24.6', 'spread': '6.4', 'groupId': 'OG004'}]}]}, {'title': 'ALP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '95.8', 'spread': '53.5', 'groupId': 'OG000'}, {'value': '77.9', 'spread': '30.6', 'groupId': 'OG001'}, {'value': '91.8', 'spread': '43.2', 'groupId': 'OG002'}, {'value': '130.0', 'spread': 'NA', 'comment': 'Standard deviation was not calculated as only 1 participant was evaluable.', 'groupId': 'OG003'}, {'value': '79.3', 'spread': '50.7', 'groupId': 'OG004'}]}]}, {'title': 'LDH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '224.8', 'spread': '88.2', 'groupId': 'OG000'}, {'value': '245.1', 'spread': '67.2', 'groupId': 'OG001'}, {'value': '235.8', 'spread': '126.9', 'groupId': 'OG002'}, {'value': '256.0', 'spread': 'NA', 'comment': 'Standard deviation was not calculated as only 1 participant was evaluable.', 'groupId': 'OG003'}, {'value': '227.8', 'spread': '45.6', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 46 up to Week 55 post study inclusion', 'unitOfMeasure': 'Units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure and \'Number Analyzed\' signifies those participants who were evaluable for the specified rows.'}, {'type': 'PRIMARY', 'title': 'Absolute Laboratory Values of Clinical Chemistry Parameters: Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'mRCC - Temsirolimus', 'description': 'Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG001', 'title': 'mRCC - Sunitinib', 'description': 'Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG002', 'title': 'mRCC - Axitinib', 'description': 'Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG003', 'title': 'MCL - Temsirolimus', 'description': 'Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG004', 'title': 'GIST - Sunitinib', 'description': 'Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.1', 'spread': '17.1', 'groupId': 'OG000'}, {'value': '33.6', 'spread': '14.4', 'groupId': 'OG001'}, {'value': '31.6', 'spread': '14.8', 'groupId': 'OG002'}, {'value': '42.0', 'spread': 'NA', 'comment': 'Standard deviation was not calculated as only 1 participant was evaluable.', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 46 up to Week 55 post study inclusion', 'unitOfMeasure': 'Grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Here N=0 signifies that participants were not evaluable at the specified time point for albumin in MCL arm.'}, {'type': 'PRIMARY', 'title': 'Absolute Laboratory Values of Clinical Chemistry Parameters: Triiodothyronine (fT3) and Free Thyroxine (fT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'mRCC - Temsirolimus', 'description': 'Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG001', 'title': 'mRCC - Sunitinib', 'description': 'Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG002', 'title': 'mRCC - Axitinib', 'description': 'Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG003', 'title': 'MCL - Temsirolimus', 'description': 'Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG004', 'title': 'GIST - Sunitinib', 'description': 'Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}], 'classes': [{'title': 'fT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': 'NA', 'comment': 'Standard deviation was not calculated as only 1 participant was evaluable.', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'fT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15.4', 'spread': 'NA', 'comment': 'Standard deviation was not calculated as only 1 participant was evaluable.', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '13.7', 'spread': '6.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 46 up to Week 55 post study inclusion', 'unitOfMeasure': 'Picomoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Here N=0 signifies that participants were not evaluable at the specified time point for fT3 and fT4 in MCL and GIST arms.'}, {'type': 'PRIMARY', 'title': 'Absolute Laboratory Values of Clinical Chemistry Parameters: Thyroid Stimulating Hormone (TSH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'mRCC - Temsirolimus', 'description': 'Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG001', 'title': 'mRCC - Sunitinib', 'description': 'Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG002', 'title': 'mRCC - Axitinib', 'description': 'Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.'}, {'id': 'OG003', 'title': 'MCL - Temsirolimus', 'description': 'Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}, {'id': 'OG004', 'title': 'GIST - Sunitinib', 'description': 'Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '2.4', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '1.1', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 46 up to Week 55 post study inclusion', 'unitOfMeasure': 'Milliunits per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Here N=0 signifies that participants were not evaluable at the specified time point for TSH in MCL arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants With mRCC, MCL or GIST', 'description': 'Participants diagnosed with mRCC, MCL or GIST who received temsirolimus, sunitinib and/or axitinib from January 2008 to December 2021 (approximately 14 years), as per routine clinical practice. Due to the non-interventional nature of the registry, no specific requirements were applied regarding the management of treatment. Dosing and duration of treatment was decided by the physician according to individual treatment requirements of the participant. Summary of product characteristics was considered: the daily dose of temsirolimus for mRCC participants was either 25 milligrams (mg) or 50 mg once per week and for MCL participants was 175 mg for first 3 weeks and later reduced to 75 mg. The daily dose for sunitinib should not exceed 75 mg or drop below 25 mg; the recommended starting dose of axitinib was 5 mg twice daily. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus, sunitinib or axitinib was discontinued or documentation was stopped for any reason.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1520'}]}, {'type': 'Participants With mRCC', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1435'}]}, {'type': 'Participants With MCL', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}]}, {'type': 'Participants With GIST', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'Participants With mRCC Who Received Temsirolimus', 'achievements': [{'groupId': 'FG000', 'numSubjects': '605'}]}, {'type': 'Participants With mRCC Who Received Sunitinib', 'achievements': [{'groupId': 'FG000', 'numSubjects': '702'}]}, {'type': 'Participants With mRCC Who Received Axitinib', 'achievements': [{'groupId': 'FG000', 'numSubjects': '237'}]}, {'type': 'Participants With MCL Who Received Temsirolimus', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}]}, {'type': 'Participants With GIST Who Received Sunitinib', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '289'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1231'}]}], 'dropWithdraws': [{'type': 'Premature discontinuation of documentation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '136'}]}, {'type': 'Type of study end not documented', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '81'}]}, {'type': 'Premature discontinuation of therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1013'}]}]}], 'recruitmentDetails': 'Data from eligible participants diagnosed with metastatic renal cell carcinoma (mRCC), relapsed or refractory mantle cell lymphoma (MCL) or gastrointestinal stromal tumors (GIST) and who were treated with temsirolimus, sunitinib and/or axitinib, as per routine clinical practice from January 2008 to December 2021 were observed in this prospective, non-interventional, STAR-TOR registry study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1520', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants With mRCC, MCL or GIST', 'description': 'Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'mRCC - Temsirolimus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '605', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Less than (<) 40 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '40 - <50 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': '50 - <60 years', 'measurements': [{'value': '106', 'groupId': 'BG000'}]}, {'title': '60 - <70 years', 'measurements': [{'value': '188', 'groupId': 'BG000'}]}, {'title': '70 - <80 years', 'measurements': [{'value': '238', 'groupId': 'BG000'}]}, {'title': '80 - <90 years', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': '90 - <100 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'mRCC - Sunitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Less than (<) 40 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '40 - <50 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': '50 - <60 years', 'measurements': [{'value': '128', 'groupId': 'BG000'}]}, {'title': '60 - <70 years', 'measurements': [{'value': '222', 'groupId': 'BG000'}]}, {'title': '70 - <80 years', 'measurements': [{'value': '252', 'groupId': 'BG000'}]}, {'title': '80 - <90 years', 'measurements': [{'value': '66', 'groupId': 'BG000'}]}, {'title': '90 - <100 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'mRCC - Axitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Less than (<) 40 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '40 - <50 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '50 - <60 years', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': '60 - <70 years', 'measurements': [{'value': '67', 'groupId': 'BG000'}]}, {'title': '70 - <80 years', 'measurements': [{'value': '92', 'groupId': 'BG000'}]}, {'title': '80 - <90 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': '90 - <100 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'MCL - Temsirolimus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Less than (<) 40 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '40 - <50 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '50 - <60 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '60 - <70 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': '70 - <80 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': '80 - <90 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': '90 - <100 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'GIST - Sunitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Less than (<) 40 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '40 - <50 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '50 - <60 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '60 - <70 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '70 - <80 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '80 - <90 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '90 - <100 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'mRCC - Temsirolimus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '605', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Male', 'measurements': [{'value': '410', 'groupId': 'BG000'}]}, {'title': 'Female', 'measurements': [{'value': '191', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'mRCC - Sunitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Male', 'measurements': [{'value': '510', 'groupId': 'BG000'}]}, {'title': 'Female', 'measurements': [{'value': '187', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'mRCC - Axitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Male', 'measurements': [{'value': '163', 'groupId': 'BG000'}]}, {'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'MCL - Temsirolimus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'GIST - Sunitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.'}, {'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.'}], 'populationDescription': 'Safety analysis set comprised of all prospectively documented participants with a histologically proven diagnosis of either mRCC, MCL or GIST and at least 1 documented administration of temsirolimus, sunitinib or axitinib or any non-Pfizer treatment. Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-28', 'size': 4462020, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-07T18:26', 'hasProtocol': True}, {'date': '2021-02-23', 'size': 5277546, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-12-07T18:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1520}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-21', 'studyFirstSubmitDate': '2008-06-13', 'resultsFirstSubmitDate': '2022-12-07', 'studyFirstSubmitQcDate': '2008-06-17', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-21', 'studyFirstPostDateStruct': {'date': '2008-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months', 'description': 'OS was defined as the time from initiation of treatment to death from any cause. In case a death was documented, but date of death was unknown, the date of death was substituted with the latest available date for the participant (last visit, last contact date, date of assessment). If no death was documented, participant was censored with the latest available contact date or assessment date within study. If these rules led to a missing duration or a negative duration, duration was set to maximum of (PFS,"1 day"). Progression free survival (PFS) was defined as time from initiation of treatment to documented disease progression or death from any cause. progression was defined as the enlargement of the measured sum by 20% or one or more new lesions. This outcome measure was analyzed using Kaplan-Meier method.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months', 'description': 'PFS was defined as time from initiation of treatment to documented disease progression or death from any cause. The presence of a progression i.e. enlargement of the measured sum by 20% or one or more new lesions was confirmed, but (a) No date was documented: the date of last intake of study medication was used as date of progression, otherwise the date of the last visit with a documented "non-progression" was used as date of progression. (b) Dates within a visit and on final documentation were contradictory, the prior date was used. In case a death was documented within survival follow-up, but no progression was documented within regular study, the date of last visit plus 1 day was used as date of progression. In case no progression was documented, participant was censored with the latest available contact date or assessment date within study. In case these rules led to a missing duration or a negative duration, duration was set to "1 day". Kaplan-Meier method was used for analysis.'}, {'measure': 'Number of Participants With Best Overall Response (BOR)', 'timeFrame': 'From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months', 'description': 'BOR included Complete Remission (CR): complete disappearance of all lesions. Partial Remission (PR): Reduction of the measured total by at least 30%. Minor remission (MR): ≥10% decrease in the sum of longest diameters of target lesions but not a PR (\\<30%). Stable Disease (SD): neither shrinkage for CR/PR nor increase for progressive disease (PD) taking as reference smallest sum of longest diameters (SLDs) since treatment start. PD: Enlargement of the measured sum by 20% or one or more new lesions. In this outcome measure, number of participants with best overall response were reported.'}, {'measure': "Number of Participants Categorized According to Physician's Global Assessment of Effectiveness", 'timeFrame': 'From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months', 'description': "In this outcome measure, number of participants were categorized according to physician's global assessment of effectiveness as very good, good, moderate, insufficient and missing. Categories were determined by investigator's discretion."}, {'measure': 'Karnofsky Performance Status (KPS) Scale', 'timeFrame': 'From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months', 'description': "Karnofsky performance score was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks."}, {'measure': 'Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status for Mantle Cell Lymphoma', 'timeFrame': 'From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months', 'description': "ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) 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/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, 2) and missing was evaluated for MCL as planned."}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months', 'description': 'An adverse event (AE) was any undesirable medical event in a participant took a medicinal product. It was not necessarily required that the event is causally related to the treatment or use of the medicinal product. An SAE was any undesirable medical event that occurred in a participant received a medicinal product or dietary supplement (including infant formula) at any dose, and that resulted in death; was life-threatening; required an unforeseen hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial impairment of the ability to perform daily activities); resulted in a congenital malformation/birth defect. TEAEs were events between first dose of study drug and up to last documented follow-up visit that were absent before treatment or that worsened relative to pretreatment state. AEs included serious and all non-serious adverse events.'}, {'measure': 'Number of Participants Who Discontinued Treatment Due to Adverse Events', 'timeFrame': 'From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months', 'description': 'An AE was any undesirable medical event in a participant took a medicinal product. It was not necessarily required that the event is causally related to the treatment or use of the medicinal product. In this outcome measure number of participants who discontinued treatment due to adverse events were reported.'}, {'measure': "Number of Participants Categorized According to Physician's Global Tolerability Assessment", 'timeFrame': 'From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months', 'description': "In this outcome measure, number of participants were categorized according to physician's global tolerability assessment as very good, good, moderate, insufficient and missing. Categories were determined by investigator's discretion."}, {'measure': 'Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit', 'timeFrame': 'Week 46 up to Week 55 post study inclusion'}, {'measure': 'Absolute Laboratory Values of Hematology Parameters: Hemoglobin A1c (HbA1c)', 'timeFrame': 'Week 46 up to Week 55 post study inclusion'}, {'measure': 'Absolute Laboratory Values of Hematology Parameters: Hemoglobin', 'timeFrame': 'Week 46 up to Week 55 post study inclusion'}, {'measure': 'Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose', 'timeFrame': 'Week 46 up to Week 55 post study inclusion'}, {'measure': 'Absolute Laboratory Values of Clinical Chemistry Parameters: Creatinine, Total Bilirubin', 'timeFrame': 'Week 46 up to Week 55 post study inclusion'}, {'measure': 'Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH)', 'timeFrame': 'Week 46 up to Week 55 post study inclusion'}, {'measure': 'Absolute Laboratory Values of Clinical Chemistry Parameters: Albumin', 'timeFrame': 'Week 46 up to Week 55 post study inclusion'}, {'measure': 'Absolute Laboratory Values of Clinical Chemistry Parameters: Triiodothyronine (fT3) and Free Thyroxine (fT4)', 'timeFrame': 'Week 46 up to Week 55 post study inclusion'}, {'measure': 'Absolute Laboratory Values of Clinical Chemistry Parameters: Thyroid Stimulating Hormone (TSH)', 'timeFrame': 'Week 46 up to Week 55 post study inclusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Carcinoma, Renal Cell, Advanced', 'Lymphoma, Mantle-Cell', 'Gastrointestinal Stroma Tumors']}, 'referencesModule': {'references': [{'pmid': '38310863', 'type': 'DERIVED', 'citation': 'Uhlig A, Bergmann L, Bogemann M, Fischer T, Goebell PJ, Leitsmann M, Reichert M, Rink M, Schlack K, Trojan L, Uhlig J, Woike M, Strauss A. Sunitinib for Metastatic Renal Cell Carcinoma: Real-World Data from the STAR-TOR Registry and Detailed Literature Review. Urol Int. 2024;108(3):198-210. doi: 10.1159/000536563. Epub 2024 Feb 2.'}, {'pmid': '33724867', 'type': 'DERIVED', 'citation': 'Strauss A, Schmid M, Rink M, Moran M, Bernhardt S, Hubbe M, Bergmann L, Schlack K, Boegemann M. Real-world outcomes in patients with metastatic renal cell carcinoma according to risk factors: the STAR-TOR registry. Future Oncol. 2021 Jun;17(18):2325-2338. doi: 10.2217/fon-2020-1020. Epub 2021 Mar 16.'}, {'pmid': '33021843', 'type': 'DERIVED', 'citation': 'Boegemann M, Schlack K, Rink M, Bernhardt S, Moran M, Hubbe M, Bergmann L, Schmid M, Strauss A. Effect of comorbidities/comedications on sunitinib outcomes for metastatic renal cell carcinoma: the STAR-TOR registry. Future Oncol. 2020 Dec;16(35):2939-2948. doi: 10.2217/fon-2020-0548. Epub 2020 Oct 6.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3066K1-4407&StudyName=Registry%20For%20Temsirolimus%2C%20Sunitinib%2C%20And%20Axitinib%20Treated%20Patients%20With%20Metastatic%20Renal%20Cell%20Carcinoma%20%28mRCC%29%2C%20Mantle%20Cell%20Lymp', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this registry is to obtain a general view as regards efficacy, tolerability and safety issues of the Torisel®, Sutent®, and/or Inlyta® therapies in patients with advanced renal cell carcinoma, recurrent / refractory mantle cell lymphoma (MCL) and gastro-intestinal stroma tumors (GIST) under the conditions of routine use', 'detailedDescription': 'Treatment of the metastatic renal cell carcinoma (mRCC) has experienced fundamental changes within a very short period of time. In the past few years, introduction of various new substances for the treatment of mRCC has therefore resulted in new scientific research questions. Temsirolimus and sunitinib are current standard therapies in the first-line treatment of mRCC. Inlyta® is a new substance that was developed for the treatment of mRCC after failure of sunitinib or cytokines.\n\nSince August 2009, Torisel® is available as another treatment option for patients with mantle cell lymphoma (MCL). In addition, Sutent® is used for patients with non-resectable / metastatic gastro-intestinal stroma tumors (GIST) after failure or intolerability of imatinib.\n\nThe routine use of drugs in the usual clinical setting faces additional challenges that generally cannot be completely reflected by clinical trials. Therefore, the purpose of this registry is to obtain a general view as regards efficacy, tolerability and safety issues of the Torisel®, Sutent®, and/or Inlyta® therapies in patients with advanced renal cell carcinoma, recurrent / refractory mantle cell lymphoma (MCL) and gastro-intestinal stroma tumors (GIST) under the conditions of routine use.\n\nTherefore, the following information is of particular interest in the course of the investigation:\n\n* Efficacy (best response, overall survival, progression-free survival)\n* Tolerability of the therapy (assessed by the physician)\n* Safety profile (overall incidence of adverse events as well as side-effect rate) of subjects with mRCC, rMCL, and GIST under treatment with Torisel®, Sutent®, and/or Inlyta®\n* Profile, comorbidities, and characteristics of subjects treated with Torisel® Sutent®, and/or Inlyta®\n* The sequence of using the systemic therapies for RCC, MCL, and GIST\n* Patient survey on the quality of life of mRCC patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Tumor patients with renal cell carcinoma (RCC), mantle cell lymphoma (MCL) or gastro-intestinal stroma tumor (GIST)\n\nGastro-Intestinal Stroma Tumor', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with proven tumor of RCC, MCL or GIST by histology.\n* Informed consent signed by patient.\n\nExclusion Criteria:\n\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00700258', 'acronym': 'STAR-TOR', 'briefTitle': 'Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR]', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'STAR-TOR- REGISTRY FOR THE EVALUATION OF THE SAFETY, TOLERABILITY AND EFFICACY OF TEMSIROLIMUS (TORISEL), SUNITINIB (SUTENT) AND AXITINIB (INLYTA) FOR THE TREATMENT OF SUBJECTS WITH ADVANCED RENAL CELL CARCINOMA (MRCC), MANTLE CELL LYMPHOMA (MCL) AND GASTRO-INTESTINAL STROMA TUMOR (GIST).', 'orgStudyIdInfo': {'id': '3066K1-4407'}, 'secondaryIdInfos': [{'id': 'B1771009', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients treated with Temsirolimus for metastatic renal cell carcinoma (mRCC) under usual care settings.', 'interventionNames': ['Drug: Temsirolimus']}, {'label': '2', 'description': 'Patients treated with Temsirolimus for mantle cell lymphoma (MCL) under usual care setting', 'interventionNames': ['Drug: Temsirolimus']}, {'label': '3', 'description': 'Patients treated with Sunitinib for metastatic renal cell carcinoma (mRCC) under usual care setting', 'interventionNames': ['Drug: Sunitinib']}, {'label': '4', 'description': 'Patients treated with Sunitinib for gastro-intestinal stroma tumor (GIST) under usual care setting', 'interventionNames': ['Drug: Sunitinib']}, {'label': '5', 'description': 'Patients treated with Axitinib after treatment with Sunitinib or Cytokine for metastatic renal cell carcinoma (mRCC)', 'interventionNames': ['Drug: Axitinib']}], 'interventions': [{'name': 'Temsirolimus', 'type': 'DRUG', 'description': 'Non-interventional study. Treatment decision already made before inclusion into the registry.', 'armGroupLabels': ['1']}, {'name': 'Temsirolimus', 'type': 'DRUG', 'description': 'Non-interventional study. Treatment decision already made before inclusion into the registry.', 'armGroupLabels': ['2']}, {'name': 'Sunitinib', 'type': 'DRUG', 'description': 'Non-interventional study. Treatment decision already made before inclusion into the registry.', 'armGroupLabels': ['3']}, {'name': 'Sunitinib', 'type': 'DRUG', 'description': 'Non-interventional study. Treatment decision already made before inclusion into the registry.', 'armGroupLabels': ['4']}, {'name': 'Axitinib', 'type': 'DRUG', 'description': 'Non-interventional study. Treatment decision already made before inclusion into the registry.', 'armGroupLabels': ['5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89070', 'city': 'Ulm', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '24534', 'city': 'Neumünster', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Dr. med. Harald Held', 'geoPoint': {'lat': 54.07399, 'lon': 9.98456}}, {'zip': '48683', 'city': 'Ahaus', 'country': 'Germany', 'facility': 'Dr. med. Hans Wilhelm Duebbers', 'geoPoint': {'lat': 52.07936, 'lon': 7.01344}}, {'zip': '92224', 'city': 'Amberg', 'country': 'Germany', 'facility': 'Dr. Ludwig Fischer von Weikersthal', 'geoPoint': {'lat': 49.44287, 'lon': 11.86267}}, {'zip': '63739', 'city': 'Aschaffenburg', 'country': 'Germany', 'facility': 'Group Practice Doctors Klausmann', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'zip': '63739', 'city': 'Aschaffenburg', 'country': 'Germany', 'facility': 'Studienzentrum Drs. Klausmann / Dr. Welslau, Haematologie-Onkologie-Diabetologie', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'zip': '02625', 'city': 'Bautzen', 'country': 'Germany', 'facility': 'Office of Detlef Muller', 'geoPoint': {'lat': 51.18035, 'lon': 14.43494}}, {'zip': '95445', 'city': 'Bayreuth', 'country': 'Germany', 'facility': 'Medilei GmbH', 'geoPoint': {'lat': 49.94782, 'lon': 11.57893}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Universitaetsklinikum Charite Campus', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '06406', 'city': 'Bernburg', 'country': 'Germany', 'facility': 'Carsten Lange', 'geoPoint': {'lat': 51.79464, 'lon': 11.7401}}, {'zip': '09117', 'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Office of Axel Belusa', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'zip': '09119', 'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Office of Ulrich Kube', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'zip': '09127', 'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Dr. Jens-Uwe Krieger', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'zip': '09130', 'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Zeisigwaldklinikum Bethanien Chemnitz', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'zip': '50677', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Steinmetz', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Klinisches Studienzentrum Urlogie', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '94469', 'city': 'Deggendorf', 'country': 'Germany', 'facility': 'Leonhard Stark', 'geoPoint': {'lat': 48.84085, 'lon': 12.96068}}, {'zip': '06846', 'city': 'Dessau', 'country': 'Germany', 'facility': 'Prof. Dr. med. Udo Rebmann', 'geoPoint': {'lat': 51.83864, 'lon': 12.24555}}, {'zip': '01127', 'city': 'Dresden', 'country': 'Germany', 'facility': "doctor's office Dr. Göhler", 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Dr.med Johannes Mohm', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '06295', 'city': 'Eisleben Lutherstadt', 'country': 'Germany', 'facility': 'Dr. med. Ralf Eckert', 'geoPoint': {'lat': 51.52754, 'lon': 11.54835}}, {'zip': '99084', 'city': 'Erfurt', 'country': 'Germany', 'facility': 'Specialist Urology', 'geoPoint': {'lat': 50.97734, 'lon': 11.03536}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Goebell', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '60596', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Prof. Dr. med. Lothar Bergmann', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '65929', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Dr. med. Gunter Derigs', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '36043', 'city': 'Fulda', 'country': 'Germany', 'facility': 'Hoffkes', 'geoPoint': {'lat': 50.55162, 'lon': 9.67518}}, {'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Dr. med. Arne Strauss', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '17475', 'city': 'Greifswald', 'country': 'Germany', 'facility': 'PD Dr. Uwe Zimmermann', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'zip': '18273', 'city': 'Güstrow', 'country': 'Germany', 'facility': 'Internistische Gemeinschaftspraxis', 'geoPoint': {'lat': 53.7972, 'lon': 12.17337}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Dr. med. Michael Rink', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '31785', 'city': 'Hamelin', 'country': 'Germany', 'facility': 'Office of Oleg Rubanov', 'geoPoint': {'lat': 52.10397, 'lon': 9.35623}}, {'zip': '95028', 'city': 'Hof', 'country': 'Germany', 'facility': 'Dr. med. Hanns-Detlev Harich', 'geoPoint': {'lat': 50.31297, 'lon': 11.91261}}, {'zip': '66421', 'city': 'Homburg/Saar', 'country': 'Germany', 'facility': 'Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie'}, {'zip': '07743', 'city': 'Jena', 'country': 'Germany', 'facility': 'Dr. med. Susan Foller', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '67655', 'city': 'Kaiserslautern', 'country': 'Germany', 'facility': 'Office of Richard Hansen', 'geoPoint': {'lat': 49.443, 'lon': 7.77161}}, {'zip': '96317', 'city': 'Kronach', 'country': 'Germany', 'facility': 'Dr. med. Martina Stauch', 'geoPoint': {'lat': 50.23963, 'lon': 11.33308}}, {'zip': '84028', 'city': 'Landshut', 'country': 'Germany', 'facility': 'Dr. med. 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