Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 12:32 PM
Study NCT ID:
NCT01710033
Status:
COMPLETED
Last Update Posted:
2012-12-26
First Post:
2012-10-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Of CP-690,550 In Stable Kidney Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C479163', 'term': 'tofacitinib'}, {'id': 'C494814', 'term': 'BID protein, human'}]}}, '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': 'Placebo, Stage 1', 'description': 'Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'CP-690,550 5 mg, Stage 1', 'description': 'CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'CP-690,550 30 mg, Stage 1 And 2', 'description': 'CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.', 'otherNumAtRisk': 10, 'otherNumAffected': 8, 'seriousNumAtRisk': 10, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Gingival hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Catheter site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Cytomegalovirus viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Tinea versicolour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Reticulocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}], 'seriousEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 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'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 5 mg, Stage 1', 'description': 'CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG002', 'title': 'CP-690,550 30 mg, Stage 1 And 2', 'description': 'CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '319', 'spread': '175', 'groupId': 'OG000'}, {'value': '1300', 'spread': '241', 'groupId': 'OG001'}, {'value': '1560', 'spread': '311', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 5 mg, Stage 1', 'description': 'CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG002', 'title': 'CP-690,550 30 mg, Stage 1 And 2', 'description': 'CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '273', 'spread': '132', 'groupId': 'OG000'}, {'value': '1090', 'spread': '150', 'groupId': 'OG001'}, {'value': '1420', 'spread': '253', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 29', 'description': 'Area under the plasma concentration time-curve from zero to 12 hour concentration \\[AUC(0-12)\\] at steady state.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all randomized participants who received at least 1 dose of study treatment. 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Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Plasma Decay Half-Life (t1/2) For CP-690,550', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 5 mg, Stage 1', 'description': 'CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG002', 'title': 'CP-690,550 30 mg, Stage 1 And 2', 'description': 'CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.36', 'spread': '0.869', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed because there were not enough participants to perform a meaningful analysis.', 'groupId': 'OG001'}, {'value': '2.94', 'spread': '0.620', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Plasma Decay Half-Life (t1/2) at Steady State For CP-690,550', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 5 mg, Stage 1', 'description': 'CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG002', 'title': 'CP-690,550 30 mg, Stage 1 And 2', 'description': 'CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.18', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '5.15', 'spread': '1.12', 'groupId': 'OG001'}, {'value': '3.71', 'spread': '0.201', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half at steady state.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo, Stage 1', 'description': 'Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG001', 'title': 'CP-690,550 5 mg, Stage 1', 'description': 'CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG003', 'title': 'CP-690,550 30 mg, Stage 1 And 2', 'description': 'CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.73', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '2.18', 'spread': '1.80', 'groupId': 'OG001'}, {'value': '1.84', 'spread': '1.13', 'groupId': 'OG002'}, {'value': '2.43', 'spread': '1.80', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, 0 hour (pre-dose) on Day 1', 'description': 'Pro-drug MMF was metabolically converted to active form MPA in the liver. The baseline for MPA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.', 'unitOfMeasure': 'Milligram per Liter (mg/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all randomized participants who received at least 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo, Stage 1', 'description': 'Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG001', 'title': 'CP-690,550 5 mg, Stage 1', 'description': 'CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG003', 'title': 'CP-690,550 30 mg, Stage 1 And 2', 'description': 'CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.25', 'spread': '2.77', 'groupId': 'OG000'}, {'value': '2.11', 'spread': '2.01', 'groupId': 'OG001'}, {'value': '1.29', 'spread': '0.48', 'groupId': 'OG002'}, {'value': '2.56', 'spread': '1.62', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hour (pre-dose) on Day 8', 'description': 'Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all randomized participants who received at least 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo, Stage 1', 'description': 'Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG001', 'title': 'CP-690,550 5 mg, Stage 1', 'description': 'CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG003', 'title': 'CP-690,550 30 mg, Stage 1 And 2', 'description': 'CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.15', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '2.36', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '1.48', 'spread': '0.63', 'groupId': 'OG002'}, {'value': '2.74', 'spread': '1.52', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hour (pre-dose) on Day 15', 'description': 'Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all randomized participants who received at least 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo, Stage 1', 'description': 'Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG001', 'title': 'CP-690,550 5 mg, Stage 1', 'description': 'CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG003', 'title': 'CP-690,550 30 mg, Stage 1 And 2', 'description': 'CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.61', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '2.68', 'spread': '2.00', 'groupId': 'OG001'}, {'value': '4.30', 'spread': '3.88', 'groupId': 'OG002'}, {'value': '3.24', 'spread': '1.71', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hour (pre-dose) on Day 29', 'description': 'Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all randomized participants who received at least 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo, Stage 1', 'description': 'Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG001', 'title': 'CP-690,550 5 mg, Stage 1', 'description': 'CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG003', 'title': 'CP-690,550 30 mg, Stage 1 And 2', 'description': 'CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.60', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '2.89', 'spread': '2.75', 'groupId': 'OG001'}, {'value': '1.75', 'spread': '1.10', 'groupId': 'OG002'}, {'value': '2.67', 'spread': '1.87', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hour (pre-dose) on Day 57', 'description': 'Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Cyclosporine (CsA) Plasma Trough Concentration at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo, Stage 1', 'description': 'Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG001', 'title': 'CP-690,550 5 mg, Stage 1', 'description': 'CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '249.50', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only 1 participant was evaluable.', 'groupId': 'OG000'}, {'value': '81.00', 'spread': '41.99', 'groupId': 'OG001'}, {'value': '173.00', 'spread': '51.11', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, 0 hour (pre-dose) on Day 1', 'description': 'The baseline for CsA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Cyclosporine (CsA) Plasma Trough Concentration at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo, Stage 1', 'description': 'Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG001', 'title': 'CP-690,550 5 mg, Stage 1', 'description': 'CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '137.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only 1 participant was evaluable.', 'groupId': 'OG000'}, {'value': '77.25', 'spread': '47.28', 'groupId': 'OG001'}, {'value': '134.00', 'spread': '17.78', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hour (pre-dose) on Day 8', 'description': 'CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Cyclosporine (CsA) Plasma Trough Concentration at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo, Stage 1', 'description': 'Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG001', 'title': 'CP-690,550 5 mg, Stage 1', 'description': 'CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '207.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only 1 participant was evaluable.', 'groupId': 'OG000'}, {'value': '86.60', 'spread': '43.71', 'groupId': 'OG001'}, {'value': '160.33', 'spread': '24.58', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hour (pre-dose) on Day 15', 'description': 'CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Cyclosporine (CsA) Plasma Trough Concentration at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo, Stage 1', 'description': 'Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG001', 'title': 'CP-690,550 5 mg, Stage 1', 'description': 'CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '226.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only 1 participant was evaluable.', 'groupId': 'OG000'}, {'value': '96.00', 'spread': '53.43', 'groupId': 'OG001'}, {'value': '125.00', 'spread': '22.34', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hour (pre-dose) on Day 29', 'description': 'CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Cyclosporine (CsA) Plasma Trough Concentration at Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo, Stage 1', 'description': 'Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG001', 'title': 'CP-690,550 5 mg, Stage 1', 'description': 'CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '292.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only 1 participant was evaluable.', 'groupId': 'OG000'}, {'value': '91.20', 'spread': '72.71', 'groupId': 'OG001'}, {'value': '152.00', 'spread': '43.28', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hour (pre-dose) on Day 57', 'description': 'CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Tacrolimus (TAC) Plasma Trough Concentration at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo, Stage 1', 'description': 'Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.75', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '7.17', 'spread': '1.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, 0 hour (pre-dose) on Day 1', 'description': 'The baseline for TAC trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Tacrolimus (TAC) Plasma Trough Concentration at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo, Stage 1', 'description': 'Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.50', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '8.00', 'spread': '1.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hour (pre-dose) on Day 8', 'description': 'TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Tacrolimus (TAC) Plasma Trough Concentration at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo, Stage 1', 'description': 'Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.00', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '6.67', 'spread': '2.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hour (pre-dose) on Day 15', 'description': 'TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Tacrolimus (TAC) Plasma Trough Concentration at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo, Stage 1', 'description': 'Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.00', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '12.67', 'spread': '4.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hour (pre-dose) on Day 29', 'description': 'TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Tacrolimus (TAC) Plasma Trough Concentration at Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo, Stage 1', 'description': 'Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.00', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '6.33', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hour (pre-dose) on Day 57', 'description': 'TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo, Stage 1', 'description': 'Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (mycophenolate mofetil \\[MMF\\] with or without calcineurin inhibitor \\[cyclosporine {CsA} or tacrolimus {TAC}\\]) as per local clinical practice in Stage 1.'}, {'id': 'FG001', 'title': 'CP-690,550 5 mg, Stage 1', 'description': 'CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.'}, {'id': 'FG002', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'FG003', 'title': 'CP-690,550 30 mg, Stage 1', 'description': 'CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1.'}, {'id': 'FG004', 'title': 'CP-690,550 30 mg, Stage 2', 'description': 'CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 2.'}], 'periods': [{'title': 'Stage 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Stage 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', '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': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo, Stage 1', 'description': 'Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'BG001', 'title': 'CP-690,550 5 mg, Stage 1', 'description': 'CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.'}, {'id': 'BG002', 'title': 'CP-690,550 15 mg, Stage 1', 'description': 'CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.'}, {'id': 'BG003', 'title': 'CP-690,550 30 mg, Stage 1 And 2', 'description': 'CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'spread': '15.0', 'groupId': 'BG000'}, {'value': '53.0', 'spread': '15.5', 'groupId': 'BG001'}, {'value': '46.0', 'spread': '17.8', 'groupId': 'BG002'}, {'value': '54.2', 'spread': '14.3', 'groupId': 'BG003'}, {'value': '52.3', 'spread': '15.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-26', 'studyFirstSubmitDate': '2012-10-16', 'resultsFirstSubmitDate': '2012-11-26', 'studyFirstSubmitQcDate': '2012-10-16', 'lastUpdatePostDateStruct': {'date': '2012-12-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-26', 'studyFirstPostDateStruct': {'date': '2012-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state.'}, {'measure': 'Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 29', 'description': 'Area under the plasma concentration time-curve from zero to 12 hour concentration \\[AUC(0-12)\\] at steady state.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) For CP-690,550', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,550', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,550', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,550', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29'}, {'measure': 'Accumulation Ratio (Rac) For CP-690,550', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 and 29', 'description': 'Rac obtained from AUC(0-12) (Day 29) divided by AUC(0-12) (Day 1).'}, {'measure': 'Plasma Decay Half-Life (t1/2) For CP-690,550', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Plasma Decay Half-Life (t1/2) at Steady State For CP-690,550', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half at steady state.'}, {'measure': 'Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline', 'timeFrame': 'Screening, 0 hour (pre-dose) on Day 1', 'description': 'Pro-drug MMF was metabolically converted to active form MPA in the liver. The baseline for MPA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.'}, {'measure': 'Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 8', 'timeFrame': '0 hour (pre-dose) on Day 8', 'description': 'Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.'}, {'measure': 'Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 15', 'timeFrame': '0 hour (pre-dose) on Day 15', 'description': 'Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.'}, {'measure': 'Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 29', 'timeFrame': '0 hour (pre-dose) on Day 29', 'description': 'Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.'}, {'measure': 'Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 57', 'timeFrame': '0 hour (pre-dose) on Day 57', 'description': 'Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.'}, {'measure': 'Cyclosporine (CsA) Plasma Trough Concentration at Baseline', 'timeFrame': 'Screening, 0 hour (pre-dose) on Day 1', 'description': 'The baseline for CsA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.'}, {'measure': 'Cyclosporine (CsA) Plasma Trough Concentration at Day 8', 'timeFrame': '0 hour (pre-dose) on Day 8', 'description': 'CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.'}, {'measure': 'Cyclosporine (CsA) Plasma Trough Concentration at Day 15', 'timeFrame': '0 hour (pre-dose) on Day 15', 'description': 'CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.'}, {'measure': 'Cyclosporine (CsA) Plasma Trough Concentration at Day 29', 'timeFrame': '0 hour (pre-dose) on Day 29', 'description': 'CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.'}, {'measure': 'Cyclosporine (CsA) Plasma Trough Concentration at Day 57', 'timeFrame': '0 hour (pre-dose) on Day 57', 'description': 'CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.'}, {'measure': 'Tacrolimus (TAC) Plasma Trough Concentration at Baseline', 'timeFrame': 'Screening, 0 hour (pre-dose) on Day 1', 'description': 'The baseline for TAC trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.'}, {'measure': 'Tacrolimus (TAC) Plasma Trough Concentration at Day 8', 'timeFrame': '0 hour (pre-dose) on Day 8', 'description': 'TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.'}, {'measure': 'Tacrolimus (TAC) Plasma Trough Concentration at Day 15', 'timeFrame': '0 hour (pre-dose) on Day 15', 'description': 'TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.'}, {'measure': 'Tacrolimus (TAC) Plasma Trough Concentration at Day 29', 'timeFrame': '0 hour (pre-dose) on Day 29', 'description': 'TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.'}, {'measure': 'Tacrolimus (TAC) Plasma Trough Concentration at Day 57', 'timeFrame': '0 hour (pre-dose) on Day 57', 'description': 'TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CP-690,550', 'kidney transplant'], 'conditions': ['Kidney Transplant']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921007&StudyName=A%20Study%20Of%20CP-690%2C550%20In%20Stable%20Kidney%20Transplant%20Patients', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This was a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of subjects. After Stage 1, one dose level was to be selected for dosing in an expanded cohort in Stage 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medically stable kidney transplant patients 6 or more months after transplantation.\n* Subjects must be on mycophenolate mofetil 1-2 gm daily\n* In Cohort 3 (and 4, if conducted) in Stage 1 and the expanded cohort in Stage 2, subjects must be on a calcineurin inhibitor-free regimen.\n\nExclusion Criteria:\n\n* Any rejection episodes in the preceding 3 months.\n* Treated with Thymoglobulin or OKT3 for acute rejection in the past 6 months.'}, 'identificationModule': {'nctId': 'NCT01710033', 'briefTitle': 'A Study Of CP-690,550 In Stable Kidney Transplant Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Phase 1, Placebo-controlled, Randomized, Sequential, Parallel-group, Dose Escalation Study to Evaluate 28-day Multiple Dose Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CP-690,550 in Stable Renal Allograft Recipients', 'orgStudyIdInfo': {'id': 'A3921007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'CP-690,550 5 mg BID', 'interventionNames': ['Drug: CP-690,550 5 mg BID']}, {'type': 'EXPERIMENTAL', 'label': 'CP-690,550 15 mg BID', 'interventionNames': ['Drug: CP-690,550 15 mg BID']}, {'type': 'EXPERIMENTAL', 'label': 'CP-690,550 30 mg BID', 'interventionNames': ['Drug: CP-690,550 30 mg BID']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tables twice daily (BID) for 28 days', 'armGroupLabels': ['Placebo']}, {'name': 'CP-690,550 5 mg BID', 'type': 'DRUG', 'description': 'CP-690,550 5 mg BID for 28 days', 'armGroupLabels': ['CP-690,550 5 mg BID']}, {'name': 'CP-690,550 15 mg BID', 'type': 'DRUG', 'description': 'CP-690,550 15 mg BID for 28 days', 'armGroupLabels': ['CP-690,550 15 mg BID']}, {'name': 'CP-690,550 30 mg BID', 'type': 'DRUG', 'description': 'CP-690,550 30 mg BID for 28 days', 'armGroupLabels': ['CP-690,550 30 mg BID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249-6860', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294-6862', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110-1092', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63110-1093', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07039', 'city': 'Livingston', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.79593, 'lon': -74.31487}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'facility': 'Pfizer Investigational Site'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}