Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT01375127
Status:
COMPLETED
Last Update Posted:
2013-10-29
First Post:
2011-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Collection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C479163', 'term': 'tofacitinib'}]}}, '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': 'Data collection was limited to clinical outcome of PTLD, CNS infection, graft failure, or death. Clinical outcomes were to be reported as serious adverse event (SAE) if they met pre-defined SAE criteria and had causal relationship to tofacitinib. Non-SAEs were not planned to be reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)', 'description': 'Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Tofacitinib 15 mg (Study A3921030, Month 1 to 6)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Tofacitinib 15 mg (Study A3921030, Month 1 to 3)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Tofacitinib 15 mg (Study A3921009)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Tofacitinib 30 mg (Study A3921009)', 'description': 'Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)', 'description': 'Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).'}, {'id': 'OG001', 'title': 'Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'OG002', 'title': 'Tofacitinib 15 mg (Study A3921030, Month 1 to 6)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'OG003', 'title': 'Tofacitinib 15 mg (Study A3921030, Month 1 to 3)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'OG004', 'title': 'Tofacitinib 15 mg (Study A3921009)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'OG005', 'title': 'Tofacitinib 30 mg (Study A3921009)', 'description': 'Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Month 12', 'description': 'All lymphoproliferative disorders diagnosed locally as PTLD based on histopathology were reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis included all eligible participants who had provided an informed consent for this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Central Nervous System (CNS) Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)', 'description': 'Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).'}, {'id': 'OG001', 'title': 'Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'OG002', 'title': 'Tofacitinib 15 mg (Study A3921030, Month 1 to 6)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'OG003', 'title': 'Tofacitinib 15 mg (Study A3921030, Month 1 to 3)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'OG004', 'title': 'Tofacitinib 15 mg (Study A3921009)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'OG005', 'title': 'Tofacitinib 30 mg (Study A3921009)', 'description': 'Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Month 12', 'description': 'Participants with CNS infection involving the brain or spinal cord, within 12 months after the last dose of tofacitinib were reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis included all eligible participants who had provided an informed consent for this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Graft Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)', 'description': 'Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).'}, {'id': 'OG001', 'title': 'Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'OG002', 'title': 'Tofacitinib 15 mg (Study A3921030, Month 1 to 6)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'OG003', 'title': 'Tofacitinib 15 mg (Study A3921030, Month 1 to 3)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'OG004', 'title': 'Tofacitinib 15 mg (Study A3921009)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'OG005', 'title': 'Tofacitinib 30 mg (Study A3921009)', 'description': 'Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Month 12', 'description': 'Graft failure which occurred within 12 months after the last dose of tofacitinib was reported. Graft failure was defined as graft nephrectomy, re-transplantation, or return to dialysis for greater than or equal to (\\>=) 6 consecutive weeks.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis included all eligible participants who had provided an informed consent for this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)', 'description': 'Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).'}, {'id': 'OG001', 'title': 'Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'OG002', 'title': 'Tofacitinib 15 mg (Study A3921030, Month 1 to 6)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'OG003', 'title': 'Tofacitinib 15 mg (Study A3921030, Month 1 to 3)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'OG004', 'title': 'Tofacitinib 15 mg (Study A3921009)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'OG005', 'title': 'Tofacitinib 30 mg (Study A3921009)', 'description': 'Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Month 12', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis included all eligible participants who had provided an informed consent for this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)', 'description': 'Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).'}, {'id': 'FG001', 'title': 'Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'FG002', 'title': 'Tofacitinib 15 mg (Study A3921030, Month 1 to 6)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'FG003', 'title': 'Tofacitinib 15 mg (Study A3921030, Month 1 to 3)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'FG004', 'title': 'Tofacitinib 15 mg (Study A3921009)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'FG005', 'title': 'Tofacitinib 30 mg (Study A3921009)', 'description': 'Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '33'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '33'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants who discontinued tofacitinib prior to the end of the planned treatment duration, or did not enroll in long-term extension studies after completing tofacitinib treatment in Phase 2a study A3921009 (NCT00106639) and Phase 2b study A3921030 (NCT00483756) were enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '83', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)', 'description': 'Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).'}, {'id': 'BG001', 'title': 'Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'BG002', 'title': 'Tofacitinib 15 mg (Study A3921030, Month 1 to 6)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'BG003', 'title': 'Tofacitinib 15 mg (Study A3921030, Month 1 to 3)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'BG004', 'title': 'Tofacitinib 15 mg (Study A3921009)', 'description': 'Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'BG005', 'title': 'Tofacitinib 30 mg (Study A3921009)', 'description': 'Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.0', 'groupId': 'BG000'}, {'value': '26.0', 'groupId': 'BG001'}, {'value': '46.8', 'spread': '13.2', 'groupId': 'BG002'}, {'value': '45.3', 'spread': '13.1', 'groupId': 'BG003'}, {'value': '46.8', 'spread': '8.5', 'groupId': 'BG004'}, {'value': '36.7', 'spread': '3.1', 'groupId': 'BG005'}, {'value': '45.8', 'spread': '13.0', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '66', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-25', 'studyFirstSubmitDate': '2011-06-13', 'resultsFirstSubmitDate': '2013-05-17', 'studyFirstSubmitQcDate': '2011-06-16', 'lastUpdatePostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-17', 'studyFirstPostDateStruct': {'date': '2011-06-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD)', 'timeFrame': 'Baseline through Month 12', 'description': 'All lymphoproliferative disorders diagnosed locally as PTLD based on histopathology were reported.'}, {'measure': 'Number of Participants With Central Nervous System (CNS) Infection', 'timeFrame': 'Baseline through Month 12', 'description': 'Participants with CNS infection involving the brain or spinal cord, within 12 months after the last dose of tofacitinib were reported.'}, {'measure': 'Number of Participants With Graft Failure', 'timeFrame': 'Baseline through Month 12', 'description': 'Graft failure which occurred within 12 months after the last dose of tofacitinib was reported. Graft failure was defined as graft nephrectomy, re-transplantation, or return to dialysis for greater than or equal to (\\>=) 6 consecutive weeks.'}, {'measure': 'Number of Participants Who Died', 'timeFrame': 'Baseline through Month 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Observational', 'clinical follow-up data'], 'conditions': ['Kidney Transplantation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921053&StudyName=Collection%20of%20follow-up%20data%20from%20CP-690%2C550-treated%20kidney%20transplant%20recipients', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is an observational study designed to collect follow-up clinical date on subjects who were treated with tofacitinib in 2 completed Phase 2 studies who either discontinued treatment prematurely or did not elect to enroll in long-term extension studies.', 'detailedDescription': 'Subjects are identified based on whether they received tofacitinib in 2 completed Phase 2 studies who either discontinued treatment prematurely or who did not elect to enroll in long-term extension studies. 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