Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-02-25 @ 4:47 PM
Study NCT ID:
NCT00484094
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2007-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Investigating Rapamune For Post-Marketing Surveillance
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': '18007181021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.', 'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Rapamune', 'description': 'Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.', 'otherNumAtRisk': 209, 'otherNumAffected': 76, 'seriousNumAtRisk': 209, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Stomatitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Coughing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Transplant rejection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Azotaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}], 'seriousEvents': [{'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Hyperparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Plasma osmolality increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Angina pectoris aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Transplant rejection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Azotaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Urinary tract disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Granulocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Polyomavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Infection susceptibility increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapamune', 'description': 'Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '54.07', 'groupId': 'OG000'}]}]}, {'title': 'ADRs', 'categories': [{'measurements': [{'value': '43.06', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '7.66', 'groupId': 'OG000'}]}]}, {'title': 'SADRs', 'categories': [{'measurements': [{'value': '2.87', 'groupId': 'OG000'}]}]}, {'title': 'Unexpected SAEs', 'categories': [{'measurements': [{'value': '2.39', 'groupId': 'OG000'}]}]}, {'title': 'Unexpected SADRs', 'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.', 'description': 'All AEs reported after the start of administration of Rapamune were considered as treatment-emergent AEs and summarized. All AEs, except for those with causal relationship to the study drug assessed as "unlikely", were considered as AEs whose causal relationship to the study drug could not be excluded and classified as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Clinically Significent Abnormal Laboratory Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapamune', 'description': 'Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.'}], 'timeFrame': 'Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.', 'description': 'Laboratory test was not mandatory because this study was a non-interventional study.', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was not performed because laboratory data were not collected during the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Biopsy-Confirmed Acute Rejection Using Banff 09 Diagnostic Categories for Renal Allograft Biopsies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapamune', 'description': 'Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.35', 'groupId': 'OG000', 'lowerLimit': '0.91', 'upperLimit': '5.79'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.', 'description': 'Renal biopsy was required to confirm the diagnosis of acute rejection. However, due to the non-interventional nature of this study, biopsy could not be mandatory. The decision of whether to perform a biopsy was made at the discretion of the investigator and the result was collected if performed.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Set: Participants with efficacy data recorded on the case report form (CRF) at 6 months (±1 month) after initiating Rapamune administration or at the time of completing Rapamune administration (whichever was earlier) were included in the Efficacy Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Alive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapamune', 'description': 'Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.51', 'groupId': 'OG000', 'lowerLimit': '98.57', 'upperLimit': '100.00'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.', 'description': "The investigator recorded the participant's survival status and evaluation date on the CRF.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Set; Participants who had available data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Survived Graft', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapamune', 'description': 'Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.51', 'groupId': 'OG000', 'lowerLimit': '98.57', 'upperLimit': '100.00'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.', 'description': 'Graft survival was defined as not showing graft loss at the time of evaluation.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Set; Participants who had available data.'}, {'type': 'SECONDARY', 'title': 'Estimated Glomerular Filtration Rate (eGFR) Calculated by Nankivell Formula', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapamune', 'description': 'Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.07', 'groupId': 'OG000', 'lowerLimit': '4.80', 'upperLimit': '113.27'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.', 'description': 'Graft function was evaluated by eGFR using Nankivell formula. The investigator recorded the date of evaluation and the calculated value on the CRF.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rapamune', 'description': 'Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '209'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '167'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}], 'dropWithdraws': [{'type': 'Discontinued', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants were enrolled between July 2011 and June 2015 from Korean health care centers.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Rapamune', 'description': 'Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.93', 'spread': '13.10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '81', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '128', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type of Transplantation', 'classes': [{'title': 'Primary Transplantation', 'categories': [{'measurements': [{'value': '199', 'groupId': 'BG000'}]}]}, {'title': 'Secondary Transplantation', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Primary transplantation: Participants received renal transplantation for the first time.\n\nSecondary transplantation: Participants received renal re-transplantation.', 'unitOfMeasure': 'Participants'}, {'title': 'Type of Donation', 'classes': [{'title': 'Cadaveric', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}]}]}, {'title': 'Living', 'categories': [{'measurements': [{'value': '132', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set: Participants who received Rapamune at least once and were evaluated on its related safety endpoints at least once.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 209}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-21', 'studyFirstSubmitDate': '2007-06-07', 'resultsFirstSubmitDate': '2016-06-02', 'studyFirstSubmitQcDate': '2007-06-07', 'lastUpdatePostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-21', 'studyFirstPostDateStruct': {'date': '2007-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs', 'timeFrame': 'Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.', 'description': 'All AEs reported after the start of administration of Rapamune were considered as treatment-emergent AEs and summarized. All AEs, except for those with causal relationship to the study drug assessed as "unlikely", were considered as AEs whose causal relationship to the study drug could not be excluded and classified as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer.'}, {'measure': 'Percentage of Participants With Clinically Significent Abnormal Laboratory Test', 'timeFrame': 'Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.', 'description': 'Laboratory test was not mandatory because this study was a non-interventional study.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Biopsy-Confirmed Acute Rejection Using Banff 09 Diagnostic Categories for Renal Allograft Biopsies', 'timeFrame': 'At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.', 'description': 'Renal biopsy was required to confirm the diagnosis of acute rejection. However, due to the non-interventional nature of this study, biopsy could not be mandatory. The decision of whether to perform a biopsy was made at the discretion of the investigator and the result was collected if performed.'}, {'measure': 'Percentage of Participants Alive', 'timeFrame': 'At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.', 'description': "The investigator recorded the participant's survival status and evaluation date on the CRF."}, {'measure': 'Percentage of Participants With Survived Graft', 'timeFrame': 'At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.', 'description': 'Graft survival was defined as not showing graft loss at the time of evaluation.'}, {'measure': 'Estimated Glomerular Filtration Rate (eGFR) Calculated by Nankivell Formula', 'timeFrame': 'At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.', 'description': 'Graft function was evaluated by eGFR using Nankivell formula. The investigator recorded the date of evaluation and the calculated value on the CRF.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rapamune', 'Safety', 'Efficacy', 'Kidney Transplantation'], 'conditions': ['Kidney Transplantation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0468X1-4411&StudyName=Study%20Investigating%20Rapamune%20For%20Post-Marketing%20Surveillance', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To provide safety and effectiveness information for Rapamune during the post-marketing period as required by Korea Food and Drug Administration (KFDA) regulations in order to identify any potential drug related treatment factors in the Korean population, such as:\n\n1. Unknown adverse reactions, especially serious adverse reactions\n2. To assess the incidence of adverse reactions under the routine drug uses\n3. Factors that may affect the safety of the drug (e.g., proteinuria)\n4. Factors that may affect the effectiveness of the drug', 'detailedDescription': 'All patients who receive Rapamune for certain period of time should be included as far as patients consent to participate'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who receive Rapamune after kidney transplantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged 13 years or older receiving renal transplants, who are newly administered Rapamune after a contract is made between Pfizer Korea and an investigator and/or an institution for conducting this study.\n\nExclusion Criteria:\n\n* Any patient who does not agree that Pfizer and companies working with Pfizer use his/her information.\n* Patients who have known hypersensitivity to Rapamune or its derivatives or any excipients in the formulation.'}, 'identificationModule': {'nctId': 'NCT00484094', 'briefTitle': 'Study Investigating Rapamune For Post-Marketing Surveillance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Post Marketing Surveillance Study To Observe Safety And Efficacy Of Rapamune', 'orgStudyIdInfo': {'id': '0468X1-4411'}, 'secondaryIdInfos': [{'id': 'B1741015', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rapamune', 'interventionNames': ['Drug: sirolimus']}], 'interventions': [{'name': 'sirolimus', 'type': 'DRUG', 'otherNames': ['Rapamune'], 'description': "Dosage and treatment duration will be decided by physician's discretion considering patient's clinical situations", 'armGroupLabels': ['Rapamune']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital (SNUH)', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '705-717', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Yeungnam University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '480-717', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': "The Catholic University of Korea Uijeongbu St. Mary's Hospital", 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '600-730', 'city': 'Pusan', 'country': 'South Korea', 'facility': 'Maryknoll Medical Center', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'zip': '134-814', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangdong Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-720', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '136-705', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '137-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '143-729', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}