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A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months. Patients will be assigned to one of three treatment groups after receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be a standard-of-care control arm. Patients will continue to take the assigned study medication for 12 months as well as other standard transplant medications such as prednisone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Treatment Arm 1 will also receive standard of care medications |
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| 2 | Experimental | Treatment Arm 2 will also receive standard of care medications |
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| 3 | Experimental | Treatment Arm 3 will also receive standard of care medications |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine | Drug | Standard of care |
| |
| CP-690,550 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) Episode 6 Months Post-Transplant | Clinical BPAR was a BPAR (category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification) associated with an increase in serum creatinine of >= 0.3 milligram per deciliter (mg/dL) and >=20 percent (%) from pre-rejection baseline. The increase in serum creatinine was assessed based on the comparison of baseline and the highest serum creatinine recorded within 24 hours (hrs) of the time of biopsy. | Baseline up to Month 6 |
| Glomerular Filtration Rate (GFR) at Month 12 | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous bolus over 5 minutes immediately after morning dosing of CP-690,550 or CsA on day of GFR evaluation. A normal GFR is greater than (>) 90 milliliter per minute (mL/min), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (<) 15 mL/min indicated kidney failure. | 2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Glomerular Filtration Rate (GFR) at Month 6 | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous bolus over 5 minutes immediately after morning dosing of CP-690,550 or CsA on day of GFR evaluation. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Little Rock | Arkansas | 72205 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Initially 7 participants were enrolled and randomized under original protocol but enrollment was terminated because 2 participants developed Grade 2B rejection. Protocol amendment 1 was implemented to increase aggregate level of immunosuppression and 331 participants were enrolled. Results of participants enrolled under amendment 1 are reported.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cyclosporine | Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
CP-690,550 15 mg BID for Months 1-6, then 10 mg BID for Months 7-12 |
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| CP-690,550 | Drug | CP-690,550 15 mg BID for Months 1-3, then 10 mg BID for Months 4-12 |
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| 2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 6 |
| Number of Participants With Progression of Chronic Allograft Lesions at Month 12 | Progression of chronic allograft lesions was defined as an increase in the Banff chronicity score (Banff-CS) in biopsy from the implantation (baseline) biopsy in a given participant. Banff-CS was the sum of the Banff scores for the 4 chronic basic lesions (allograft glomerulopathy [cg] + interstitial fibrosis [ci] + tubular atrophy [ct] + vascular intimal thickening [cv]).The Banff-CS ranged from 0-12, higher score indicated greater lesions and Month 12 Banff-CS greater than the implantation biopsy score indicated progression of lesions. | Month 12 |
| Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) 12 Months Post Transplant | Clinical BPAR was a BPAR (category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification) associated with an increase in serum creatinine of >= 0.3 mg/dL and >=20% from pre-rejection baseline. The increase in serum creatinine was assessed based on the comparison of baseline and the highest serum creatinine recorded within 24 hrs of the time of biopsy. | Baseline up to Month 12 |
| Number of Participants With Treated Clinical Acute Rejection | Treated clinical acute rejection was defined as an acute rejection episode that was diagnosed based on local biopsy readout and received anti-rejection treatment. | Month 6, 12 |
| Number of Participants With Combined Banff Rejection Categories (Categories 2, 3, and 4) | Banff 97: standard classification for scoring and classifying rejection of kidney transplant biopsies in 6 diagnostic categories: normal, antibody-mediated rejection, borderline changes: 'suspicious' for acute cellular rejection, acute/active cellular rejection, chronic/sclerosing allograft nephropathy, and other. Combined Banff rejection calculated from categories of antibody-mediated rejection (Category 2) plus borderline changes (Category 3) plus acute rejection (Category 4), as interpreted by the central pathologist. | Month 6, 12 |
| Number of Participants With Graft Loss | Graft loss was defined as graft nephrectomy, participant death, re-transplantation, or return to dialysis for >=6 consecutive weeks. | Month 6, 12 |
| Number of Participants With Efficacy Failure | Efficacy failure was the first occurrence of clinical BPAR diagnosed by the central pathologist or graft loss including participant death. | Month 6, 12 |
| Number of Participants Who Died | Month 6, 12 |
| Lymphocyte Subset | The absolute cell counts of cluster of differentiation 3 (CD3): T-lymphocytes, cluster of differentiation 19 (CD19): B-lymphocytes, and cluster of differentiation 56 (CD56): assumed natural killer cells, were determined using flow cytometry. | Month 1, 3, 6, 12 |
| Population Pharmacokinetics (PK) | Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules. | Pre-dose-2(P-2), Pre-dose(P), 0.5,1,2 hr post-dose(PD) on Day14, Month(M) 3; P,1,2 hr PD on M1; P, 0.5, 2, 4 hr PD on M6; P-2, P, 0.5 hr PD on M9, M12 as per randomization in CP-690,550 treated; P on M3 and P, 2, 4 hr PD on M6 in CsA treated participants |
| Glomerular Filtration Rate (GFR) by The Nankivell Equation | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated was estimated by creatinine clearance (CLcr) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine) plus (0.25*body weight) minus (0.5*serum urea) minus (100 per height square) plus (35 for male/25 for female). A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure. | Month 1, 3, 6, 9, 12 |
| Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight*(140 minus age in years) divided by (72*serum creatinine). For females value obtained was multiplied by 0.85. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure. | Month 1, 3, 6, 9, 12 |
| Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR by MDRD equation = 170 * (serum creatinine)^(-0.999) * (age in years)^(-0.176) * (0.762 if female) * (1.18 if black) * (blood urea nitrogen concentration)^(-0.170) * (serum albumin concentration)^(0.318).A normal GFR is >90 mL/min/1.73 square meter (m^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure. | Month 1, 3, 6, 9, 12 |
| Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using abbreviated MDRD equation. GFR by abbreviated MDRD equation= 186 * (serum creatinine)^(-1.154) * (age in years)^(-0.203) * (0.742 if female) * (1.210 if black). A normal GFR is >90 mL/min/1.73 m^2, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure. | Month 1, 3, 6, 9, 12 |
| Number of Participants With Clinically Significant Infections | Clinically significant infection was defined as the presence of documented infection confirmed by culture, biopsy, genomic, or serologic findings post-randomization and requiring hospitalization or parenteral anti-infective treatment, or otherwise deemed significant by the investigator. | Baseline up to Month 12 |
| 36-Item Short-Form Health Survey (SF-36) | SF-36: standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores. Total of 11 variables were analyzed (8 subscales,2 composite subscales and Question(Q) 2 "how would you rate your health in general now?"(range 1=better, 5=worst). The score for a section (except Q2) is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). | Baseline, Month 6, 12 |
| End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | ESRD-SCL:43-item disease specific self-administered questionnaire. Participants' rated question"At the moment,how much do you suffer?"for each item on 5 point scale,ranged (Ra) 0(not at all)to 4(extremely).Consisted of 6 subscales:cardiac and renal dysfunction;Ra 0-28,increased(In) growth of gum and hair;Ra 0-20,limited cognitive capacity;Ra 0-32,limited physical capacity;Ra 0 - 40,side effects (SEs) of corticosteroids;Ra 0-20,transplantation associated psychological distress(TAPD);Ra 0-32(higher scores=greater dysfunction for each subscale).Total score:0-172,higher scores=greater dysfunction. | Baseline, Month 6, 12 |
| Severity of Dyspepsia Assessment (SODA) | SODA:17-item health scale, assessed participant-reported perceptions of dyspepsia;consists of 3 subscales:Pain Intensity (6-items to assess pain and intensity of abdominal [Ab] discomfort; Range (Ra):2-47, higher score= greater pain and Ab discomfort), Non-Pain Symptoms (7-items to assess severity and impact of non-pain symptoms:burping/belching,heartburn,bloating,flatulence,sour taste,nausea,and bad breath; Ra:7-35,higher scores = increased symptom severity and influence), and Satisfaction (4-items to assess degree of satisfaction with Ab discomfort; Ra:2-23,higher scores= more satisfaction). | Baseline, Month 6, 12 |
| Los Angeles |
| California |
| 90048 |
| United States |
| Pfizer Investigational Site | Los Angeles | California | 90095 | United States |
| Pfizer Investigational Site | Palo Alto | California | 94304 | United States |
| Pfizer Investigational Site | San Diego | California | 92123 | United States |
| Pfizer Investigational Site | San Francisco | California | 94115 | United States |
| Pfizer Investigational Site | San Francisco | California | 94143 | United States |
| Pfizer Investigational Site | Stanford | California | 94305 | United States |
| Pfizer Investigational Site | Aurora | Colorado | 80045 | United States |
| Pfizer Investigational Site | New Haven | Connecticut | 06504 | United States |
| Pfizer Investigational Site | New Haven | Connecticut | 06510 | United States |
| Pfizer Investigational Site | Gainesville | Florida | 32610 | United States |
| Pfizer Investigational Site | Gainsville | Florida | 32610 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33606 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60611 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60637 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21201 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02215 | United States |
| Pfizer Investigational Site | Springfield | Massachusetts | 01107 | United States |
| Pfizer Investigational Site | Springfield | Massachusetts | 01199 | United States |
| Pfizer Investigational Site | Ann Arbor | Michigan | 48109 | United States |
| Pfizer Investigational Site | Detroit | Michigan | 48202 | United States |
| Pfizer Investigational Site | Rochester | Minnesota | 55905 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63110 | United States |
| Pfizer Investigational Site | Livingston | New Jersey | 07039 | United States |
| Pfizer Investigational Site | New York | New York | 10029 | United States |
| Pfizer Investigational Site | Valhalla | New York | 10595 | United States |
| Pfizer Investigational Site | Chapel Hill | North Carolina | 27514 | United States |
| Pfizer Investigational Site | Chapel Hill | North Carolina | 27599-7155 | United States |
| Pfizer Investigational Site | Chapel Hill | North Carolina | 27599-7211 | United States |
| Pfizer Investigational Site | Chapel Hill | North Carolina | 27599-7360 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97239 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19102 | United States |
| Pfizer Investigational Site | Charleston | South Carolina | 29425 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75204 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75246 | United States |
| Pfizer Investigational Site | Fort Worth | Texas | 76104 | United States |
| Pfizer Investigational Site | Camperdown | New South Wales | 2050 | Australia |
| Pfizer Investigational Site | Westmead | New South Wales | 2145 | Australia |
| Pfizer Investigational Site | Adelaide | South Australia | 5000 | Australia |
| Pfizer Investigational Site | Woodville | South Australia | 5011 | Australia |
| Pfizer Investigational Site | Clayton | Victoria | 3168 | Australia |
| Pfizer Investigational Site | Parkville | Victoria | 3050 | Australia |
| Pfizer Investigational Site | Anderlecht | 1070 | Belgium |
| Pfizer Investigational Site | Leuven | 3000 | Belgium |
| Pfizer Investigational Site | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 04038-002 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 04039-050 | Brazil |
| Pfizer Investigational Site | Edmonton | Alberta | T6G 2B7 | Canada |
| Pfizer Investigational Site | Prague | 140 21 | Czechia |
| Pfizer Investigational Site | Nantes | 44093 | France |
| Pfizer Investigational Site | Paris | 75743 | France |
| Pfizer Investigational Site | Toulouse | 31059 | France |
| Pfizer Investigational Site | Vandœuvre-lès-Nancy | 54500 | France |
| Pfizer Investigational Site | Berlin | 10117 | Germany |
| Pfizer Investigational Site | Hamburg | 20246 | Germany |
| Pfizer Investigational Site | Bologna | 40138 | Italy |
| Pfizer Investigational Site | Roma | 00168 | Italy |
| Pfizer Investigational Site | Rotterdam | 3015 GD | Netherlands |
| Pfizer Investigational Site | Oslo | 0027 | Norway |
| Pfizer Investigational Site | Warsaw | 02-006 | Poland |
| Pfizer Investigational Site | Wroclaw | 50-417 | Poland |
| Pfizer Investigational Site | Coimbra | 3000-075 | Portugal |
| Pfizer Investigational Site | Lisbon | 1069-166 | Portugal |
| Pfizer Investigational Site | Seoul | 110-744 | South Korea |
| Pfizer Investigational Site | Seoul | 120-752 | South Korea |
| Pfizer Investigational Site | Seoul | 138-736 | South Korea |
| Pfizer Investigational Site | Barcelona | Barcelona | 08036 | Spain |
| Pfizer Investigational Site | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| FG001 | CP-690,550 15 mg for Months 1 to 6 | CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. |
| FG002 | CP-690,550 15 mg for Months 1 to 3 | CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cyclosporine | Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months. |
| BG001 | CP-690,550 15 mg for Months 1 to 6 | CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. |
| BG002 | CP-690,550 15 mg for Months 1 to 3 | CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
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| Primary | Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) Episode 6 Months Post-Transplant | Clinical BPAR was a BPAR (category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification) associated with an increase in serum creatinine of >= 0.3 milligram per deciliter (mg/dL) and >=20 percent (%) from pre-rejection baseline. The increase in serum creatinine was assessed based on the comparison of baseline and the highest serum creatinine recorded within 24 hours (hrs) of the time of biopsy. | Full analysis set (FAS) with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. | Posted | Number | participants | Baseline up to Month 6 |
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| Primary | Glomerular Filtration Rate (GFR) at Month 12 | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous bolus over 5 minutes immediately after morning dosing of CP-690,550 or CsA on day of GFR evaluation. A normal GFR is greater than (>) 90 milliliter per minute (mL/min), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (<) 15 mL/min indicated kidney failure. | FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) includes only participants with evaluable data for this measure at Month 12. | Posted | Mean | Standard Deviation | mL/min | 2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 12 |
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| Secondary | Glomerular Filtration Rate (GFR) at Month 6 | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous bolus over 5 minutes immediately after morning dosing of CP-690,550 or CsA on day of GFR evaluation. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure. | FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) includes only participants with evaluable data for this measure at Month 6. | Posted | Mean | Standard Deviation | mL/min | 2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 6 |
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| Secondary | Number of Participants With Progression of Chronic Allograft Lesions at Month 12 | Progression of chronic allograft lesions was defined as an increase in the Banff chronicity score (Banff-CS) in biopsy from the implantation (baseline) biopsy in a given participant. Banff-CS was the sum of the Banff scores for the 4 chronic basic lesions (allograft glomerulopathy [cg] + interstitial fibrosis [ci] + tubular atrophy [ct] + vascular intimal thickening [cv]).The Banff-CS ranged from 0-12, higher score indicated greater lesions and Month 12 Banff-CS greater than the implantation biopsy score indicated progression of lesions. | Per protocol (PP) population: all randomized participants who received at least 1 dose of study treatment; excluding participants who had a protocol deviation thought to affect the analyses. Here, N (Number of Participants Analyzed) includes only participants with evaluable data for this measure at both baseline and Month 12. | Posted | Number | participants | Month 12 |
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| Secondary | Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) 12 Months Post Transplant | Clinical BPAR was a BPAR (category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification) associated with an increase in serum creatinine of >= 0.3 mg/dL and >=20% from pre-rejection baseline. The increase in serum creatinine was assessed based on the comparison of baseline and the highest serum creatinine recorded within 24 hrs of the time of biopsy. | FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. | Posted | Number | participants | Baseline up to Month 12 |
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| Secondary | Number of Participants With Treated Clinical Acute Rejection | Treated clinical acute rejection was defined as an acute rejection episode that was diagnosed based on local biopsy readout and received anti-rejection treatment. | FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively. | Posted | Number | participants | Month 6, 12 |
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| Secondary | Number of Participants With Combined Banff Rejection Categories (Categories 2, 3, and 4) | Banff 97: standard classification for scoring and classifying rejection of kidney transplant biopsies in 6 diagnostic categories: normal, antibody-mediated rejection, borderline changes: 'suspicious' for acute cellular rejection, acute/active cellular rejection, chronic/sclerosing allograft nephropathy, and other. Combined Banff rejection calculated from categories of antibody-mediated rejection (Category 2) plus borderline changes (Category 3) plus acute rejection (Category 4), as interpreted by the central pathologist. | FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who were evaluable at given time point for each group, respectively. | Posted | Number | participants | Month 6, 12 |
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| Secondary | Number of Participants With Graft Loss | Graft loss was defined as graft nephrectomy, participant death, re-transplantation, or return to dialysis for >=6 consecutive weeks. | FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively. | Posted | Number | participants | Month 6, 12 |
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| Secondary | Number of Participants With Efficacy Failure | Efficacy failure was the first occurrence of clinical BPAR diagnosed by the central pathologist or graft loss including participant death. | FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively. | Posted | Number | participants | Month 6, 12 |
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| Secondary | Number of Participants Who Died | FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively. | Posted | Number | participants | Month 6, 12 |
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| Secondary | Lymphocyte Subset | The absolute cell counts of cluster of differentiation 3 (CD3): T-lymphocytes, cluster of differentiation 19 (CD19): B-lymphocytes, and cluster of differentiation 56 (CD56): assumed natural killer cells, were determined using flow cytometry. | FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure; and 'n' signifies those participants who were evaluable at given time point for each group, respectively. | Posted | Mean | Standard Deviation | cells per microliter | Month 1, 3, 6, 12 |
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| Secondary | Population Pharmacokinetics (PK) | Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules. | Not Posted | Mean | Standard Deviation | nanogram*hour per milliliter (ng*hr/mL) | Pre-dose-2(P-2), Pre-dose(P), 0.5,1,2 hr post-dose(PD) on Day14, Month(M) 3; P,1,2 hr PD on M1; P, 0.5, 2, 4 hr PD on M6; P-2, P, 0.5 hr PD on M9, M12 as per randomization in CP-690,550 treated; P on M3 and P, 2, 4 hr PD on M6 in CsA treated participants | |||||||||||||||||||||||||||||||||||
| Secondary | Glomerular Filtration Rate (GFR) by The Nankivell Equation | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated was estimated by creatinine clearance (CLcr) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine) plus (0.25*body weight) minus (0.5*serum urea) minus (100 per height square) plus (35 for male/25 for female). A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure. | FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using Last Observation Carried Forward (LOCF). | Posted | Mean | Standard Deviation | mL/min | Month 1, 3, 6, 9, 12 |
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| Secondary | Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight*(140 minus age in years) divided by (72*serum creatinine). For females value obtained was multiplied by 0.85. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure. | FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using LOCF. | Posted | Mean | Standard Deviation | mL/min | Month 1, 3, 6, 9, 12 |
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| Secondary | Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR by MDRD equation = 170 * (serum creatinine)^(-0.999) * (age in years)^(-0.176) * (0.762 if female) * (1.18 if black) * (blood urea nitrogen concentration)^(-0.170) * (serum albumin concentration)^(0.318).A normal GFR is >90 mL/min/1.73 square meter (m^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure. | FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using LOCF. | Posted | Mean | Standard Deviation | mL/min/1.73 m^2 | Month 1, 3, 6, 9, 12 |
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| Secondary | Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using abbreviated MDRD equation. GFR by abbreviated MDRD equation= 186 * (serum creatinine)^(-1.154) * (age in years)^(-0.203) * (0.742 if female) * (1.210 if black). A normal GFR is >90 mL/min/1.73 m^2, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure. | FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using LOCF. | Posted | Mean | Standard Deviation | mL/min per 1.73 m^2 | Month 1, 3, 6, 9, 12 |
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| Secondary | Number of Participants With Clinically Significant Infections | Clinically significant infection was defined as the presence of documented infection confirmed by culture, biopsy, genomic, or serologic findings post-randomization and requiring hospitalization or parenteral anti-infective treatment, or otherwise deemed significant by the investigator. | FAS: all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to Month 12 |
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| Secondary | 36-Item Short-Form Health Survey (SF-36) | SF-36: standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores. Total of 11 variables were analyzed (8 subscales,2 composite subscales and Question(Q) 2 "how would you rate your health in general now?"(range 1=better, 5=worst). The score for a section (except Q2) is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). | FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure; and 'n' signifies those participants who were evaluable at given time point for each group, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 6, 12 |
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| Secondary | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | ESRD-SCL:43-item disease specific self-administered questionnaire. Participants' rated question"At the moment,how much do you suffer?"for each item on 5 point scale,ranged (Ra) 0(not at all)to 4(extremely).Consisted of 6 subscales:cardiac and renal dysfunction;Ra 0-28,increased(In) growth of gum and hair;Ra 0-20,limited cognitive capacity;Ra 0-32,limited physical capacity;Ra 0 - 40,side effects (SEs) of corticosteroids;Ra 0-20,transplantation associated psychological distress(TAPD);Ra 0-32(higher scores=greater dysfunction for each subscale).Total score:0-172,higher scores=greater dysfunction. | FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure; and 'n' signifies those participants who were evaluable at given time point for each group, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 6, 12 |
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| Secondary | Severity of Dyspepsia Assessment (SODA) | SODA:17-item health scale, assessed participant-reported perceptions of dyspepsia;consists of 3 subscales:Pain Intensity (6-items to assess pain and intensity of abdominal [Ab] discomfort; Range (Ra):2-47, higher score= greater pain and Ab discomfort), Non-Pain Symptoms (7-items to assess severity and impact of non-pain symptoms:burping/belching,heartburn,bloating,flatulence,sour taste,nausea,and bad breath; Ra:7-35,higher scores = increased symptom severity and influence), and Satisfaction (4-items to assess degree of satisfaction with Ab discomfort; Ra:2-23,higher scores= more satisfaction). | Data not analyzed since the SODA instrument was found irrelevant in the treated population. | Posted | Baseline, Month 6, 12 |
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Not provided
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cyclosporine | Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months. | 65 | 109 | 105 | 109 | ||
| EG001 | CP-690,550 15 mg for Months 1 to 6 | CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. | 76 | 106 | 102 | 106 | ||
| EG002 | CP-690,550 15 mg for Months 1 to 3 | CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. | 74 | 107 | 105 | 107 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Aplastic anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Electromechanical dissociation | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Left ventricular hypertrophy | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Congenital cystic kidney disease | Congenital, familial and genetic disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Adrenal mass | Endocrine disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Blindness cortical | Eye disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pancreatitis necrotising | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Brain death | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Drug interaction | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hernia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Kidney transplant rejection | Immune system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Serum sickness | Immune system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Transplant rejection | Immune system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Arteriovenous fistula site infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| BK virus infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bacterial pyelonephritis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bacteriuria | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cytomegalovirus colitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cytomegalovirus gastroenteritis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cytomegalovirus oesophagitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Genital herpes | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Herpes ophthalmic | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Incision site infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Keratitis herpetic | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Perinephric abscess | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Peritoneal infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Polyomavirus-associated nephropathy | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Prostatic abscess | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Retinitis viral | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Tuberculosis gastrointestinal | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urinary tract infection fungal | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Chronic allograft nephropathy | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Graft complication | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Graft dysfunction | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Graft loss | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Graft thrombosis | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Perirenal haematoma | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Post procedural discharge | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Post procedural haematuria | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal graft loss | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal lymphocele | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urethral injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Wound secretion | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Electroencephalogram abnormal | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypercreatininaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Epstein-Barr virus associated lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
| |
| Areflexia | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bladder irritation | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Haemorrhage urinary tract | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal artery occlusion | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal vein thrombosis | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urinary fistula | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Epididymitis | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bladder catheter removal | Surgical and medical procedures | MedDRA 13.0 | Non-systematic Assessment |
| |
| Arterial haemorrhage | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Ischaemia | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Malignant hypertension | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Superior vena caval occlusion | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Vascular insufficiency | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Polycythaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Left ventricular hypertrophy | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gingival hypertrophy | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Transplant rejection | Immune system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| BK virus infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Epstein-Barr viraemia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Genital herpes | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Polyomavirus-associated nephropathy | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Complications of transplant surgery | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Graft complication | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Post procedural discharge | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Wound secretion | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Viral test positive | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Sensory disturbance | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Testicular swelling | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hirsutism | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypertrichosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Incisional drainage | Surgical and medical procedures | MedDRA 13.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| C479163 | tofacitinib |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| 45 to 64 Years |
|
| Greater Than or Equal to (>=) 65 Years |
|
| Male |
|
| OG002 | CP-690,550 15 mg for Months 1 to 3 | CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. |
|
|
| OG002 | CP-690,550 15 mg for Months 1 to 3 | CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. |
|
|
CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
| OG002 | CP-690,550 15 mg for Months 1 to 3 | CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. |
|
|
| OG002 | CP-690,550 15 mg for Months 1 to 3 | CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. |
|
|
| CP-690,550 15 mg for Months 1 to 3 |
CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. |
|
|
CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
| OG002 | CP-690,550 15 mg for Months 1 to 3 | CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. |
|
|
CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. |
|
|
CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. |
|
|
|
|
| CP-690,550 15 mg for Months 1 to 3 |
CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. |
|
|
CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
| OG002 | CP-690,550 15 mg for Months 1 to 3 | CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. |
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| OG002 | CP-690,550 15 mg for Months 1 to 3 | CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. |
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| OG002 | CP-690,550 15 mg for Months 1 to 3 | CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. |
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| OG002 | CP-690,550 15 mg for Months 1 to 3 | CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. |
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CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
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CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
| OG002 | CP-690,550 15 mg for Months 1 to 3 | CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. |
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CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. |
| OG002 | CP-690,550 15 mg for Months 1 to 3 | CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. |
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| OG002 | CP-690,550 15 mg for Months 1 to 3 | CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. |
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