Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT00697112
Status:
COMPLETED
Last Update Posted:
2014-01-22
First Post:
2008-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study Evaluating The Use Of Sirolimus In Recipients Of Kidney Allografts From Expanded Criteria Donors (ECD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, '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': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).', 'otherNumAtRisk': 52, 'otherNumAffected': 42, 'seriousNumAtRisk': 52, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Tinea versicolour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Peritonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Pseudomonas infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Varicose ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Blood creatine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Trigeminal neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Visual field defect NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Muscle haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Conjunctival irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Vulvovaginal human papilloma virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Mouth injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Breast calcifications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Haematospermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Transplant rejection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}, {'term': 'Epidermal naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.00'}], 'seriousEvents': [{'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Klebsiella infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia escherichia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Zygomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neurological decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transplant rejection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leg amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood creatine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'classes': [{'title': 'Calcineurin inhibitor (CNI) nephrotoxicity', 'categories': [{'measurements': [{'value': '40.38', 'groupId': 'OG000', 'lowerLimit': '27.01', 'upperLimit': '54.90'}]}]}, {'title': 'Chronic allograft nephropathy', 'categories': [{'measurements': [{'value': '25.00', 'groupId': 'OG000', 'lowerLimit': '14.03', 'upperLimit': '38.95'}]}]}, {'title': 'Metabolic disorders', 'categories': [{'measurements': [{'value': '5.77', 'groupId': 'OG000', 'lowerLimit': '1.21', 'upperLimit': '15.95'}]}]}, {'title': 'To prevent chronic allograft nephropathy', 'categories': [{'measurements': [{'value': '5.77', 'groupId': 'OG000', 'lowerLimit': '1.21', 'upperLimit': '15.95'}]}]}, {'title': 'Tumoral history', 'categories': [{'measurements': [{'value': '5.77', 'groupId': 'OG000', 'lowerLimit': '1.21', 'upperLimit': '15.95'}]}]}, {'title': 'Virological status', 'categories': [{'measurements': [{'value': '5.77', 'groupId': 'OG000', 'lowerLimit': '1.21', 'upperLimit': '15.95'}]}]}, {'title': 'Delay graft function', 'categories': [{'measurements': [{'value': '3.85', 'groupId': 'OG000', 'lowerLimit': '0.47', 'upperLimit': '13.21'}]}]}, {'title': 'Expanded criteria donor characteristics', 'categories': [{'measurements': [{'value': '3.85', 'groupId': 'OG000', 'lowerLimit': '0.47', 'upperLimit': '13.21'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '1.92', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '10.26'}]}]}, {'title': 'To prevent CNI nephrotoxicity', 'categories': [{'measurements': [{'value': '1.92', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '10.26'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'The study employ a questionnaire which included different clinical criteria to determine the main medical reason for the introduction of sirolimus (Rapamune) therapy after renal transplant. The physician responsible selected the one that was considered the main reason for introduction of sirolimus (Rapamune) as base immunosuppressive therapy.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population included all participants who were treated with Rapamune for at least 4 or 5 weeks.'}, {'type': 'SECONDARY', 'title': 'Probability of Graft Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'comment': 'Confidence interval was not calculated as none of the participants had graft failure.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Graft survival was considered in participants who did not experience graft failure. Graft failure was determined by return to dialysis for a period of at least 12 weeks with no return of function, or graft loss whichever occurred sooner.', 'unitOfMeasure': 'probability of graft survival', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.'}, {'type': 'SECONDARY', 'title': 'Probability of no Acute Rejection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.960', 'groupId': 'OG000', 'lowerLimit': '0.908', 'upperLimit': '1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Diagnosis of acute rejection was made via kidney biopsy. Categorization of biopsies with suspected acute rejection was based on histological findings using updated 1997 Banff criteria: Grade 1A: significant interstitial infiltration (greater than \\[\\>\\] 25 percent \\[%\\] of parenchyma affected) and foci of moderate tubulitis (5-10 cells/tubular cross section), Grade 1B: significant interstitial infiltration (\\>25% of parenchyma affected) and severe tubulitis (\\>10 mononuclear cells/tubular cross section), Grade 2A: mild-moderate intimal arteritis, Grade 2B: severe intimal arteritis comprising \\>25% of the luminal area and Grade 3: transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells. Probability of no acute rejection throughout the sirolimus (Rapamune) therapy was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'probability of no acute rejection', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.'}, {'type': 'SECONDARY', 'title': 'Probability of Participant Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.979', 'groupId': 'OG000', 'lowerLimit': '0.938', 'upperLimit': '1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': "Participant's survival defined as participant living with or without a functioning graft. Probability of participant survival throughout the sirolimus (Rapamune) therapy was estimated using Kaplan-Meier method.", 'unitOfMeasure': 'probability of participant survival', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.'}, {'type': 'SECONDARY', 'title': 'Average Dose of Immunosuppressive Drugs Administered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'classes': [{'title': 'Baseline: CsA (C0) (n=3)', 'categories': [{'measurements': [{'value': '200.00', 'spread': '50.00', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: CsA (C2) (n=3)', 'categories': [{'measurements': [{'value': '306.67', 'spread': '83.27', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Tacrolimus (n=40)', 'categories': [{'measurements': [{'value': '5.74', 'spread': '2.73', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 or 2: Tacrolimus (n=12)', 'categories': [{'measurements': [{'value': '4.79', 'spread': '2.28', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 or 2: Sirolimus (n=44)', 'categories': [{'measurements': [{'value': '2.43', 'spread': '0.84', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 or 5: CsA (C0) (n=1)', 'categories': [{'measurements': [{'value': '150.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only 1 participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 or 5: Tacrolimus (n=6)', 'categories': [{'measurements': [{'value': '3.67', 'spread': '2.93', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 or 5: Sirolimus (n=42)', 'categories': [{'measurements': [{'value': '2.52', 'spread': '0.80', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 or 13: Tacrolimus (n=4)', 'categories': [{'measurements': [{'value': '4.00', 'spread': '2.55', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 or 13: Sirolimus (n=47)', 'categories': [{'measurements': [{'value': '2.45', 'spread': '0.94', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 or 25: Tacrolimus (n=2)', 'categories': [{'measurements': [{'value': '4.21', 'spread': '3.95', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 or 25: Sirolimus (n=46)', 'categories': [{'measurements': [{'value': '2.35', 'spread': '0.99', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 or 53: CsA (C0) (n=1)', 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only 1 participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 or 53: Tacrolimus (n=1)', 'categories': [{'measurements': [{'value': '3.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only 1 participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 or 53: Sirolimus (n=36)', 'categories': [{'measurements': [{'value': '2.05', 'spread': '0.89', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53', 'description': 'Immunosuppressive drugs administered included cyclosporin A (CsA) administration based on monitoring of plasma trough levels (C0), CsA administration based on monitoring of plasma levels 2-hours after CsA dose (C2), tacrolimus, and sirolimus (Rapamune).', 'unitOfMeasure': 'milligram per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. N(number of participants analyzed)=participants evaluable for this measure. n=participants evaluable at given time point for specified immunosuppressive. Results not reported for CsA C0 at Week 1/2, 12/13, 24/25; CsA C2 at Week 1/2, 4/5, 12/13, 24/25, 52/53; sirolimus at baseline as no participants evaluable at those time points.'}, {'type': 'SECONDARY', 'title': 'Average Blood Level of Immunosuppressive Drugs Administered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'classes': [{'title': 'Baseline: CsA (C0) (n=3)', 'categories': [{'measurements': [{'value': '144.00', 'spread': '36.66', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: CsA (C2) (n=3)', 'categories': [{'measurements': [{'value': '580.67', 'spread': '251.64', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Tacrolimus (n=40)', 'categories': [{'measurements': [{'value': '7.82', 'spread': '2.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 or 2: Tacrolimus (n=12)', 'categories': [{'measurements': [{'value': '8.12', 'spread': '3.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 or 2: Sirolimus (n=44)', 'categories': [{'measurements': [{'value': '8.55', 'spread': '3.83', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 or 5: CsA (C0) (n=1)', 'categories': [{'measurements': [{'value': '136.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only 1 participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 or 5: Tacrolimus (n=6)', 'categories': [{'measurements': [{'value': '7.00', 'spread': '5.60', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 or 5: Sirolimus (n=42)', 'categories': [{'measurements': [{'value': '7.81', 'spread': '3.33', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 or 13: Tacrolimus (n=4)', 'categories': [{'measurements': [{'value': '5.42', 'spread': '3.86', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 or 13: Sirolimus (n=47)', 'categories': [{'measurements': [{'value': '7.39', 'spread': '2.25', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 or 25: Tacrolimus (n=2)', 'categories': [{'measurements': [{'value': '4.15', 'spread': '1.91', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 or 25: Sirolimus (n=46)', 'categories': [{'measurements': [{'value': '7.75', 'spread': '2.68', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 or 53: CsA (C0) (n=1)', 'categories': [{'measurements': [{'value': '86.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only 1 participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 or 53: Tacrolimus (n=1)', 'categories': [{'measurements': [{'value': '2.40', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only 1 participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 or 53: Sirolimus (n=36)', 'categories': [{'measurements': [{'value': '7.44', 'spread': '2.54', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53', 'description': 'Immunosuppressive drugs administered included cyclosporin A (CsA) administration based on monitoring of plasma trough levels (C0), CsA administration based on monitoring of plasma levels 2-hours after CsA dose (C2), tacrolimus, and sirolimus (Rapamune).', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. N(number of participants analyzed)=participants evaluable for this measure. n=participants evaluable at given time point for specified immunosuppressive. Results not reported for CsA C0 at Week 1/2, 12/13, 24/25; CsA C2 at Week 1/2, 4/5, 12/13, 24/25, 52/53; sirolimus at baseline as no participants evaluable at those time points.'}, {'type': 'SECONDARY', 'title': 'Average Creatinine Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'classes': [{'title': 'Baseline (n=51)', 'categories': [{'measurements': [{'value': '45.40', 'spread': '19.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 or 2 (n=49)', 'categories': [{'measurements': [{'value': '50.56', 'spread': '18.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 or 5 (n=47)', 'categories': [{'measurements': [{'value': '51.51', 'spread': '21.45', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 or 13 (n=48)', 'categories': [{'measurements': [{'value': '50.95', 'spread': '18.91', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 or 25 (n=46)', 'categories': [{'measurements': [{'value': '49.52', 'spread': '19.77', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 or 53 (n=38)', 'categories': [{'measurements': [{'value': '53.24', 'spread': '22.60', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53', 'description': 'Creatinine clearance (CCr) is a measure of glomerular filtration rate (GMFR), an index of kidney function. CCr is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliter per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.', 'unitOfMeasure': 'milliliter per minute (mL/min)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Average Proteinuria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'classes': [{'title': 'Baseline (n=29)', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 or 2 (n=24)', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 or 5 (n=24)', 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.60', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 or 13 (n=25)', 'categories': [{'measurements': [{'value': '0.48', 'spread': '0.89', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 or 25 (n=23)', 'categories': [{'measurements': [{'value': '0.60', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 or 53 (n=18)', 'categories': [{'measurements': [{'value': '0.45', 'spread': '0.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53', 'description': 'Proteinuria defined as the presence of an excess of serum proteins in the urine. Normal value of proteinuria is below 0.15 grams per 24 hours (g/24 hr).', 'unitOfMeasure': 'g/24 hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'classes': [{'categories': [{'measurements': [{'value': '15.38', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Month 12', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Inefficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Month 12', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'classes': [{'categories': [{'measurements': [{'value': '15.38', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Month 12', 'description': 'An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Participants who discontinued sirolimus (Rapamune) therapy prematurely due to AE were obliged to discontinue sirolimus (Rapamune) therapy permanently, are reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.'}, {'type': 'SECONDARY', 'title': 'Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'classes': [{'title': 'Baseline (n=24)', 'categories': [{'measurements': [{'value': '24.48', 'spread': '3.65', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 or 2 (n=18)', 'categories': [{'measurements': [{'value': '23.74', 'spread': '3.69', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 or 5 (n=24)', 'categories': [{'measurements': [{'value': '24.94', 'spread': '4.26', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 or 13 (n=17)', 'categories': [{'measurements': [{'value': '24.70', 'spread': '3.99', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 or 25 (n=17)', 'categories': [{'measurements': [{'value': '25.01', 'spread': '3.76', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 or 53 (n=13)', 'categories': [{'measurements': [{'value': '24.06', 'spread': '3.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53', 'description': 'BMI was calculated as weight divided by height squared and measured as kilogram per square meter (kg/m\\^2).', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Body Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'classes': [{'title': 'Baseline: Feverless (n=21)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 or 2: Feverless (n=26)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 or 5: Feverless (n=25)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 or 13: Feverless (n=17)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 or 13: Fever (n=17)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 or 25: Feverless (n=17)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 or 53: Feverless (n=14)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53', 'description': 'Body temperature was measured in degree Celsius. Each participants were classified into three different categories based on their body temperature: body temperature less than 35 degree Celsius = hypothermia, body temperature between 35 to 37.5 degree Celsius = feverless, and body temperature greater than 37.5 degree Celsius = fever.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points. Results for hypothermia not reported as none of the participants was found hypothermic."}, {'type': 'SECONDARY', 'title': 'Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'classes': [{'title': 'Baseline: Systolic BP (n=48)', 'categories': [{'measurements': [{'value': '127.8', 'spread': '15.8', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Diastolic BP (n=48)', 'categories': [{'measurements': [{'value': '77.2', 'spread': '11.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 or 2: Systolic BP (n=48)', 'categories': [{'measurements': [{'value': '125.7', 'spread': '13.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 or 2: Diastolic BP (n=48)', 'categories': [{'measurements': [{'value': '77.6', 'spread': '9.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 or 5: Systolic BP (n=45)', 'categories': [{'measurements': [{'value': '127.4', 'spread': '19.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 or 5: Diastolic BP (n=45)', 'categories': [{'measurements': [{'value': '75.6', 'spread': '9.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 or 13: Systolic BP (n=47)', 'categories': [{'measurements': [{'value': '131.4', 'spread': '17.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 or 13: Diastolic BP (n=47)', 'categories': [{'measurements': [{'value': '79.3', 'spread': '9.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 or 25: Systolic BP (n=40)', 'categories': [{'measurements': [{'value': '128.9', 'spread': '18.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 or 25: Diastolic BP (n=40)', 'categories': [{'measurements': [{'value': '77.0', 'spread': '9.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 or 53: Systolic BP (n=37)', 'categories': [{'measurements': [{'value': '127.5', 'spread': '15.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 or 53: Diastolic BP (n=37)', 'categories': [{'measurements': [{'value': '77.8', 'spread': '9.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53', 'description': "Systolic and diastolic blood pressure (BP) was measured after the participant had rested in the supine position for at least 5 minutes with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg).", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'classes': [{'title': 'Baseline (n=26)', 'categories': [{'measurements': [{'value': '74.0', 'spread': '7.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 or 2 (n=27)', 'categories': [{'measurements': [{'value': '77.4', 'spread': '7.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 or 5 (n=31)', 'categories': [{'measurements': [{'value': '77.2', 'spread': '9.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 or 13 (n=22)', 'categories': [{'measurements': [{'value': '73.2', 'spread': '9.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 or 25 (n=22)', 'categories': [{'measurements': [{'value': '75.3', 'spread': '10.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 or 53 (n=22)', 'categories': [{'measurements': [{'value': '76.2', 'spread': '9.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'classes': [{'title': 'Baseline (n=46)', 'categories': [{'measurements': [{'value': '70.78', 'spread': '14.50', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 or 2 (n=46)', 'categories': [{'measurements': [{'value': '71.17', 'spread': '13.76', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 or 5 (n=45)', 'categories': [{'measurements': [{'value': '70.87', 'spread': '14.25', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 or 13 (n=43)', 'categories': [{'measurements': [{'value': '72.85', 'spread': '13.11', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 or 25 (n=37)', 'categories': [{'measurements': [{'value': '72.18', 'spread': '13.48', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 or 53 (n=34)', 'categories': [{'measurements': [{'value': '70.96', 'spread': '13.77', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53', 'unitOfMeasure': 'kilogram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Physical Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'classes': [{'categories': [{'measurements': [{'value': '69.23', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Month 12', 'description': 'Physical abnormalities included all the abnormalities related to general disorders and administration site conditions, gastrointestinal disorders, skin and subcutaneous tissue disorders, vascular disorders, investigations, infections and infestations, eye disorders, respiratory, thoracic and mediastinal disorders, nervous system disorders, musculoskeletal and connective tissue disorders, injury, poisoning and procedural complications, surgical and medical procedures, psychiatric disorders, neoplasms benign, malignant and unspecified (incl cysts and polyps), ear and labyrinth disorders, and congenital, familial and genetic disorders.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'classes': [{'categories': [{'measurements': [{'value': '88.46', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Month 12', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'classes': [{'categories': [{'measurements': [{'value': '40.38', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Month 12', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinically-Significant Electrocardiogram Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Month 12', 'description': "Standard 12-lead ECG was performed. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization), QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia's formula (QTcF = QT divided by cube root of RR interval) and heart rate (time interval between consecutive heart beats \\[RR interval\\]).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinically-Significant Radiological Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Month 12', 'description': 'Radiological examination was performed to evaluate presence or signs of infections or pneumonitis.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'Met the Inclusion Criteria', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Did not meet inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sirolimus', 'description': 'Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \\[\\>\\] 1.5 milligram per deciliter \\[mg/dL\\], cerebrovascular accident as cause of death or history of hypertension).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.7', 'spread': '14.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-03', 'studyFirstSubmitDate': '2008-06-10', 'resultsFirstSubmitDate': '2013-12-03', 'studyFirstSubmitQcDate': '2008-06-12', 'lastUpdatePostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-03', 'studyFirstPostDateStruct': {'date': '2008-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy', 'timeFrame': 'Baseline', 'description': 'The study employ a questionnaire which included different clinical criteria to determine the main medical reason for the introduction of sirolimus (Rapamune) therapy after renal transplant. The physician responsible selected the one that was considered the main reason for introduction of sirolimus (Rapamune) as base immunosuppressive therapy.'}], 'secondaryOutcomes': [{'measure': 'Probability of Graft Survival', 'timeFrame': 'Month 12', 'description': 'Graft survival was considered in participants who did not experience graft failure. Graft failure was determined by return to dialysis for a period of at least 12 weeks with no return of function, or graft loss whichever occurred sooner.'}, {'measure': 'Probability of no Acute Rejection', 'timeFrame': 'Month 12', 'description': 'Diagnosis of acute rejection was made via kidney biopsy. Categorization of biopsies with suspected acute rejection was based on histological findings using updated 1997 Banff criteria: Grade 1A: significant interstitial infiltration (greater than \\[\\>\\] 25 percent \\[%\\] of parenchyma affected) and foci of moderate tubulitis (5-10 cells/tubular cross section), Grade 1B: significant interstitial infiltration (\\>25% of parenchyma affected) and severe tubulitis (\\>10 mononuclear cells/tubular cross section), Grade 2A: mild-moderate intimal arteritis, Grade 2B: severe intimal arteritis comprising \\>25% of the luminal area and Grade 3: transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells. Probability of no acute rejection throughout the sirolimus (Rapamune) therapy was estimated using Kaplan-Meier method.'}, {'measure': 'Probability of Participant Survival', 'timeFrame': 'Month 12', 'description': "Participant's survival defined as participant living with or without a functioning graft. Probability of participant survival throughout the sirolimus (Rapamune) therapy was estimated using Kaplan-Meier method."}, {'measure': 'Average Dose of Immunosuppressive Drugs Administered', 'timeFrame': 'Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53', 'description': 'Immunosuppressive drugs administered included cyclosporin A (CsA) administration based on monitoring of plasma trough levels (C0), CsA administration based on monitoring of plasma levels 2-hours after CsA dose (C2), tacrolimus, and sirolimus (Rapamune).'}, {'measure': 'Average Blood Level of Immunosuppressive Drugs Administered', 'timeFrame': 'Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53', 'description': 'Immunosuppressive drugs administered included cyclosporin A (CsA) administration based on monitoring of plasma trough levels (C0), CsA administration based on monitoring of plasma levels 2-hours after CsA dose (C2), tacrolimus, and sirolimus (Rapamune).'}, {'measure': 'Average Creatinine Clearance', 'timeFrame': 'Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53', 'description': 'Creatinine clearance (CCr) is a measure of glomerular filtration rate (GMFR), an index of kidney function. CCr is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliter per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.'}, {'measure': 'Average Proteinuria', 'timeFrame': 'Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53', 'description': 'Proteinuria defined as the presence of an excess of serum proteins in the urine. Normal value of proteinuria is below 0.15 grams per 24 hours (g/24 hr).'}, {'measure': 'Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy', 'timeFrame': 'Baseline up to Month 12'}, {'measure': 'Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Inefficacy', 'timeFrame': 'Baseline up to Month 12'}, {'measure': 'Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Adverse Events', 'timeFrame': 'Baseline up to Month 12', 'description': 'An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Participants who discontinued sirolimus (Rapamune) therapy prematurely due to AE were obliged to discontinue sirolimus (Rapamune) therapy permanently, are reported.'}, {'measure': 'Body Mass Index', 'timeFrame': 'Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53', 'description': 'BMI was calculated as weight divided by height squared and measured as kilogram per square meter (kg/m\\^2).'}, {'measure': 'Number of Participants With Body Temperature', 'timeFrame': 'Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53', 'description': 'Body temperature was measured in degree Celsius. Each participants were classified into three different categories based on their body temperature: body temperature less than 35 degree Celsius = hypothermia, body temperature between 35 to 37.5 degree Celsius = feverless, and body temperature greater than 37.5 degree Celsius = fever.'}, {'measure': 'Blood Pressure', 'timeFrame': 'Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53', 'description': "Systolic and diastolic blood pressure (BP) was measured after the participant had rested in the supine position for at least 5 minutes with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg)."}, {'measure': 'Pulse Rate', 'timeFrame': 'Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53'}, {'measure': 'Body Weight', 'timeFrame': 'Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53'}, {'measure': 'Percentage of Participants With Physical Abnormalities', 'timeFrame': 'Baseline up to Month 12', 'description': 'Physical abnormalities included all the abnormalities related to general disorders and administration site conditions, gastrointestinal disorders, skin and subcutaneous tissue disorders, vascular disorders, investigations, infections and infestations, eye disorders, respiratory, thoracic and mediastinal disorders, nervous system disorders, musculoskeletal and connective tissue disorders, injury, poisoning and procedural complications, surgical and medical procedures, psychiatric disorders, neoplasms benign, malignant and unspecified (incl cysts and polyps), ear and labyrinth disorders, and congenital, familial and genetic disorders.'}, {'measure': 'Percentage of Participants With Adverse Events', 'timeFrame': 'Baseline up to Month 12', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.'}, {'measure': 'Percentage of Participants With Serious Adverse Events', 'timeFrame': 'Baseline up to Month 12', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.'}, {'measure': 'Percentage of Participants With Clinically-Significant Electrocardiogram Abnormalities', 'timeFrame': 'Baseline up to Month 12', 'description': "Standard 12-lead ECG was performed. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization), QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia's formula (QTcF = QT divided by cube root of RR interval) and heart rate (time interval between consecutive heart beats \\[RR interval\\])."}, {'measure': 'Percentage of Participants With Clinically-Significant Radiological Abnormalities', 'timeFrame': 'Baseline up to Month 12', 'description': 'Radiological examination was performed to evaluate presence or signs of infections or pneumonitis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Transplantation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0468H-102385&StudyName=Study%20Evaluating%20The%20Use%20Of%20Sirolimus%20In%20Recipients%20Of%20Kidney%20Allografts%20From%20Expanded%20Criteria%20Donors%20%28ECD%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study is to examine the clinical outcomes of the use of sirolimus as base therapy in kidney allograft recipients from Expanded Criteria Donors (ECD) under conditions of routine clinical practice. The primary objective is to identify the current criteria/reasons to use sirolimus as base therapy in this selected population and define and understand the emerging patterns of immunosuppressive treatment with sirolimus.', 'detailedDescription': 'pilot study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Kidney allograft recipients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or older.\n* Patients who received a renal transplant (primary, secondary, tertiary, etc.) without pancreas, from Expanded Criteria Donors (ECD), 3 months prior and no later than 1 year at the time of study enrollment.\n* Patients who provided informed consent.\n* Patients without sirolimus as base therapy.\n\nExclusion Criteria:\n\n* Patients who are unwilling or unable to provide informed consent or who lack a legal guardian or designee able to provide consent on their behalf.\n* Patients who are unable to complete the study.\n* Patients who are participating in another clinical trial during the last 6 months.\n* Pregnant or lactating patients.'}, 'identificationModule': {'nctId': 'NCT00697112', 'briefTitle': 'Study Evaluating The Use Of Sirolimus In Recipients Of Kidney Allografts From Expanded Criteria Donors (ECD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Surveillance Registry Of Sirolimus Use In Recipients Of Kidney Allograft From Expanded Criteria Donors (ECD)', 'orgStudyIdInfo': {'id': '0468H-102385'}, 'secondaryIdInfos': [{'id': 'B1741025'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'interventionNames': ['Drug: Sirolimus']}], 'interventions': [{'name': 'Sirolimus', 'type': 'DRUG', 'otherNames': ['Rapamune'], 'description': 'Non interventional. Sirolimus administered by Principal Investigator per standard practice and labeling.', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1425', 'city': 'Caba', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Pfizer Investigational Site'}, {'zip': 'C1093AAS', 'city': 'Caba', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Pfizer Investigational Site'}, {'zip': 'C1181ACH', 'city': 'Caba', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Pfizer Investigational Site'}, {'city': 'Caba', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Pfizer Investigational Site'}, {'zip': '5016', 'city': 'Barrio General Paz', 'state': 'Córdoba Province', 'country': 'Argentina', 'facility': 'Pfizer Investigational Site'}, {'zip': '3000', 'city': 'Santa Fe', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -31.64881, 'lon': -60.70868}}, {'zip': '4000', 'city': 'San Miguel de Tucumán', 'state': 'Tucumán Province', 'country': 'Argentina', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': '5016', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}