Trial Outcomes & Findings for Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients (NCT NCT00658359)
NCT ID: NCT00658359
Last Updated: 2018-02-23
Results Overview
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. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
178 participants
Primary outcome timeframe
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Results posted on
2018-02-23
Participant Flow
Participants were recruited and studied between 18 August 2008 and 18 February 2015. Those with 6-month time-weighted concentrations at 2-hours postdose (TWC2) above the median (Amendment 3), negative/unknown Epstein-Barr virus (EBV) at transplant, cytomegalovirus disease or lymphocyte-depleting agents posttransplant (Amendment 4) were discontinued
Participants who had completed 12 months treatment with tofacitinib or cyclosporine (CsA) in previous parent study (A3921030) continued study drugs for an additional 60 months in this extension study.
Participant milestones
| Measure |
Tofacitinib More Intensive (MI)
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Cyclosporine
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Overall Study
STARTED
|
54
|
64
|
60
|
|
Overall Study
COMPLETED
|
8
|
36
|
15
|
|
Overall Study
NOT COMPLETED
|
46
|
28
|
45
|
Reasons for withdrawal
| Measure |
Tofacitinib More Intensive (MI)
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Cyclosporine
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Overall Study
Death
|
2
|
3
|
1
|
|
Overall Study
Adverse Event
|
9
|
13
|
6
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Includes protocol Amendments 3 and 4
|
29
|
2
|
31
|
|
Overall Study
Withdrawal by Subject
|
2
|
7
|
4
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
Baseline Characteristics
Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients
Baseline characteristics by cohort
| Measure |
Cyclosporine
n=64 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=60 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=54 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.4 Years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
45.7 Years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
48.5 Years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
46.8 Years
STANDARD_DEVIATION 12.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72Population: Safety Analysis Set. n is the number of participants remaining at risk at each visit.
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. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.
Outcome measures
| Measure |
Cyclosporine
n=61 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=55 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=52 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit
Month 12
|
4.69 Percentage of Participants
Interval 2.46 to 6.91
|
8.33 Percentage of Participants
Interval 5.33 to 11.34
|
3.70 Percentage of Participants
Interval 1.54 to 5.87
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit
Month 15 (n=59,54,44)
|
7.81 Percentage of Participants
Interval 4.99 to 10.64
|
10.00 Percentage of Participants
Interval 6.74 to 13.26
|
18.52 Percentage of Participants
Interval 14.07 to 22.97
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit
Month 18 (n=57,52,41)
|
9.40 Percentage of Participants
Interval 6.33 to 12.48
|
13.33 Percentage of Participants
Interval 9.64 to 17.03
|
20.46 Percentage of Participants
Interval 15.83 to 25.09
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit
Month 24 (n=54,48,34)
|
11.02 Percentage of Participants
Interval 7.71 to 14.33
|
18.33 Percentage of Participants
Interval 14.13 to 22.54
|
24.49 Percentage of Participants
Interval 19.51 to 29.47
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit
Month 30 (n=49,34,23)
|
12.80 Percentage of Participants
Interval 9.23 to 16.36
|
25.42 Percentage of Participants
Interval 20.64 to 30.21
|
29.46 Percentage of Participants
Interval 24.0 to 34.92
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit
Month 36 (n=46,28,12)
|
14.62 Percentage of Participants
Interval 10.81 to 18.42
|
27.83 Percentage of Participants
Interval 22.79 to 32.87
|
34.89 Percentage of Participants
Interval 28.2 to 41.57
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit
Month 42 (n=40,28,11)
|
14.62 Percentage of Participants
Interval 10.81 to 18.42
|
27.83 Percentage of Participants
Interval 22.79 to 32.87
|
34.89 Percentage of Participants
Interval 28.2 to 41.57
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit
Month 48 (n=37,28,11)
|
16.81 Percentage of Participants
Interval 12.68 to 20.93
|
27.83 Percentage of Participants
Interval 22.79 to 32.87
|
34.89 Percentage of Participants
Interval 28.2 to 41.57
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit
Month 54 (n=36,25,10)
|
19.05 Percentage of Participants
Interval 14.62 to 23.48
|
33.08 Percentage of Participants
Interval 27.52 to 38.64
|
34.89 Percentage of Participants
Interval 28.2 to 41.57
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit
Month 60 (n=34,21,10)
|
19.05 Percentage of Participants
Interval 14.62 to 23.48
|
36.13 Percentage of Participants
Interval 30.26 to 41.99
|
34.89 Percentage of Participants
Interval 28.2 to 41.57
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit
Month 66 (n=29,19,8)
|
19.05 Percentage of Participants
Interval 14.62 to 23.48
|
36.13 Percentage of Participants
Interval 30.26 to 41.99
|
34.89 Percentage of Participants
Interval 28.2 to 41.57
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit
Month 72 (n=24,15,7)
|
21.94 Percentage of Participants
Interval 17.05 to 26.84
|
40.12 Percentage of Participants
Interval 33.73 to 46.51
|
43.03 Percentage of Participants
Interval 34.35 to 51.7
|
PRIMARY outcome
Timeframe: Months 12 through 72.Population: Safety Analysis Set. Percentages use n (the number of participants with malignancies: 7,8,8 respectively) and include 1 participant in CsA and 2 in Tofacitinib LI from before dose reduction to 5 mg by Month 18 was implemented (protocol Amendment 1)
All treatment-emergent malignancies in Study A3921050 were included as collected on the Malignancy Case Report Form page.
Outcome measures
| Measure |
Cyclosporine
n=64 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=60 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=54 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Percentage of Participants With Malignancies
|
10.9 Percentage of Participants
|
13.3 Percentage of Participants
|
14.8 Percentage of Participants
|
PRIMARY outcome
Timeframe: Month 36Population: Full analysis set (FAS, which was defined the same as the Safety Analysis Set). The analysis included 1 participant in CsA and 2 in Tofacitinib LI from before protocol Amendment 1. Only subjects at Month 36 with GFR calculations were included.
Glomerular filtration rate (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 (IV) bolus over 5 minutes immediately after morning dosing of Tofacitinib or CsA on day of GFR evaluation. Blood samples for iohexol (3 millilitres \[mL\] each to provide a minimum of 1 mL serum) were collected into appropriately labeled tubes containing no additives at 120, 180, 240, and 300 minutes after the end of the iohexol IV bolus. A normal GFR is greater than (\>) 90 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.
Outcome measures
| Measure |
Cyclosporine
n=39 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=30 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=13 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Least Squares Means of Measured Glomerular Filtration Rate (GFR) (Iohexol Serum Clearance in Milliliters Per Minute [mL/Min])
|
67.63 mL/min
Standard Error 3.38
|
76.86 mL/min
Standard Error 3.74
|
75.86 mL/min
Standard Error 5.35
|
PRIMARY outcome
Timeframe: Month 36Population: FAS. Only participants with Banff CS values at both Day 0 and Month 36 visits were included.
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 36 Banff-CS greater than the implantation biopsy score indicated progression of lesions.
Outcome measures
| Measure |
Cyclosporine
n=24 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=18 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=8 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Percentage of Participants With Progression of Chronic Allograft Lesions at Month 36
|
87.50 Percentage of Participants
|
77.78 Percentage of Participants
|
87.50 Percentage of Participants
|
PRIMARY outcome
Timeframe: Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72Population: FAS. n is the number of participants remaining at risk at each visit.
BPAR was category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.
Outcome measures
| Measure |
Cyclosporine
n=60 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=54 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=51 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 12
|
6.25 Percentage of Participants
Interval 3.7 to 8.8
|
10.00 Percentage of Participants
Interval 6.74 to 13.26
|
5.56 Percentage of Participants
Interval 2.93 to 8.18
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 15 (n=59,54,50)
|
7.81 Percentage of Participants
Interval 4.99 to 10.64
|
10.00 Percentage of Participants
Interval 6.74 to 13.26
|
7.41 Percentage of Participants
Interval 4.41 to 10.41
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 18 (n=57,54,48)
|
9.40 Percentage of Participants
Interval 6.33 to 12.48
|
10.00 Percentage of Participants
Interval 6.74 to 13.26
|
7.41 Percentage of Participants
Interval 4.41 to 10.41
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 24 (n=55,53,42)
|
9.40 Percentage of Participants
Interval 6.33 to 12.48
|
10.00 Percentage of Participants
Interval 6.74 to 13.26
|
7.41 Percentage of Participants
Interval 4.41 to 10.41
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 30 (n=51,37,28)
|
9.40 Percentage of Participants
Interval 6.33 to 12.48
|
10.00 Percentage of Participants
Interval 6.74 to 13.26
|
7.41 Percentage of Participants
Interval 4.41 to 10.41
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 36 (n=48,28,14)
|
11.18 Percentage of Participants
Interval 7.82 to 14.54
|
10.00 Percentage of Participants
Interval 6.74 to 13.26
|
7.41 Percentage of Participants
Interval 4.41 to 10.41
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 42 (n=40,28,13)
|
13.34 Percentage of Participants
Interval 9.61 to 17.08
|
10.00 Percentage of Participants
Interval 6.74 to 13.26
|
7.41 Percentage of Participants
Interval 4.41 to 10.41
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 48 (n=38,28,13)
|
13.34 Percentage of Participants
Interval 9.61 to 17.08
|
10.00 Percentage of Participants
Interval 6.74 to 13.26
|
7.41 Percentage of Participants
Interval 4.41 to 10.41
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 54 (n=38,27,12)
|
13.34 Percentage of Participants
Interval 9.61 to 17.08
|
10.00 Percentage of Participants
Interval 6.74 to 13.26
|
7.41 Percentage of Participants
Interval 4.41 to 10.41
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 60 (n=36,23,11)
|
13.34 Percentage of Participants
Interval 9.61 to 17.08
|
10.00 Percentage of Participants
Interval 6.74 to 13.26
|
7.41 Percentage of Participants
Interval 4.41 to 10.41
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 66 (n=31,20,10)
|
13.34 Percentage of Participants
Interval 9.61 to 17.08
|
10.00 Percentage of Participants
Interval 6.74 to 13.26
|
7.41 Percentage of Participants
Interval 4.41 to 10.41
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 72 (n=28,18,10)
|
13.34 Percentage of Participants
Interval 9.61 to 17.08
|
10.00 Percentage of Participants
Interval 6.74 to 13.26
|
7.41 Percentage of Participants
Interval 4.41 to 10.41
|
PRIMARY outcome
Timeframe: Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72Population: FAS. n is the number of participants remaining at risk at each visit.
Treated clinical acute rejection was defined as an acute rejection episode that was diagnosed based on local biopsy readout and received anti-rejection treatment. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.
Outcome measures
| Measure |
Cyclosporine
n=55 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=56 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=49 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Kaplan-Meier Analysis of Percentage of Participants With Treated Clinical Acute Rejection by Visit
Month 12
|
14.06 Percentage of Participants
Interval 10.41 to 17.72
|
6.67 Percentage of Participants
Interval 3.96 to 9.38
|
9.26 Percentage of Participants
Interval 5.94 to 12.58
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treated Clinical Acute Rejection by Visit
Month 15 (n=53,56,48)
|
17.19 Percentage of Participants
Interval 13.22 to 21.16
|
6.67 Percentage of Participants
Interval 3.96 to 9.38
|
11.11 Percentage of Participants
Interval 7.51 to 14.71
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treated Clinical Acute Rejection by Visit
Month 18 (n=51,54,46)
|
18.75 Percentage of Participants
Interval 14.64 to 22.86
|
10.00 Percentage of Participants
Interval 6.74 to 13.26
|
11.11 Percentage of Participants
Interval 7.51 to 14.71
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treated Clinical Acute Rejection by Visit
Month 24 (n=49,52,40)
|
18.75 Percentage of Participants
Interval 14.64 to 22.86
|
11.67 Percentage of Participants
Interval 8.18 to 15.15
|
11.11 Percentage of Participants
Interval 7.51 to 14.71
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treated Clinical Acute Rejection by Visit
Month 30 (n=46,37,27)
|
20.48 Percentage of Participants
Interval 16.21 to 24.75
|
11.67 Percentage of Participants
Interval 8.18 to 15.15
|
11.11 Percentage of Participants
Interval 7.51 to 14.71
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treated Clinical Acute Rejection by Visit
Month 36 (n=42,29,14)
|
23.94 Percentage of Participants
Interval 19.38 to 28.49
|
11.67 Percentage of Participants
Interval 8.18 to 15.15
|
11.11 Percentage of Participants
Interval 7.51 to 14.71
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treated Clinical Acute Rejection by Visit
Month 42 (n=36,29,13)
|
27.56 Percentage of Participants
Interval 22.74 to 32.38
|
11.67 Percentage of Participants
Interval 8.18 to 15.15
|
11.11 Percentage of Participants
Interval 7.51 to 14.71
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treated Clinical Acute Rejection by Visit
Month 48 (n=34,29,13)
|
27.56 Percentage of Participants
Interval 22.74 to 32.38
|
11.67 Percentage of Participants
Interval 8.18 to 15.15
|
11.11 Percentage of Participants
Interval 7.51 to 14.71
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treated Clinical Acute Rejection by Visit
Month 54 (n=33,28,12)
|
29.69 Percentage of Participants
Interval 24.69 to 34.69
|
11.67 Percentage of Participants
Interval 8.18 to 15.15
|
11.11 Percentage of Participants
Interval 7.51 to 14.71
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treated Clinical Acute Rejection by Visit
Month 60 (n=30,24,11)
|
29.69 Percentage of Participants
Interval 24.69 to 34.69
|
11.67 Percentage of Participants
Interval 8.18 to 15.15
|
11.11 Percentage of Participants
Interval 7.51 to 14.71
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treated Clinical Acute Rejection by Visit
Month 66 (n=25,21,9)
|
29.69 Percentage of Participants
Interval 24.69 to 34.69
|
11.67 Percentage of Participants
Interval 8.18 to 15.15
|
11.11 Percentage of Participants
Interval 7.51 to 14.71
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treated Clinical Acute Rejection by Visit
Month 72 (n=22,18,9)
|
29.69 Percentage of Participants
Interval 24.69 to 34.69
|
11.67 Percentage of Participants
Interval 8.18 to 15.15
|
11.11 Percentage of Participants
Interval 7.51 to 14.71
|
SECONDARY outcome
Timeframe: Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72Population: FAS. n is the number of participants remaining at risk at each visit.
Efficacy failure was the first occurrence of BPAR diagnosed by the central pathologist or graft loss including participant death. BPAR (category acute rejection) was interpreted by the central blinded pathologist according to the Banff 97 working classification. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.
Outcome measures
| Measure |
Cyclosporine
n=60 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=54 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=51 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 36 (n=51,48,42)
|
15.94 Percentage of Participants
Interval 12.04 to 19.83
|
15.19 Percentage of Participants
Interval 11.26 to 19.12
|
16.71 Percentage of Participants
Interval 12.43 to 20.99
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 12
|
6.25 Percentage of Participants
Interval 3.7 to 8.8
|
10.00 Percentage of Participants
Interval 6.74 to 13.26
|
5.56 Percentage of Participants
Interval 2.93 to 8.18
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 15 (n=58,54,49)
|
7.81 Percentage of Participants
Interval 4.99 to 10.64
|
10.00 Percentage of Participants
Interval 6.74 to 13.26
|
9.26 Percentage of Participants
Interval 5.94 to 12.58
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 18 (n=56,54,49)
|
10.99 Percentage of Participants
Interval 7.69 to 14.29
|
10.00 Percentage of Participants
Interval 6.74 to 13.26
|
9.26 Percentage of Participants
Interval 5.94 to 12.58
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 24 (n=54,54,46)
|
10.99 Percentage of Participants
Interval 7.69 to 14.29
|
10.00 Percentage of Participants
Interval 6.74 to 13.26
|
14.81 Percentage of Participants
Interval 10.75 to 18.88
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 30 (n=53,52,46)
|
12.64 Percentage of Participants
Interval 9.12 to 16.16
|
10.00 Percentage of Participants
Interval 6.74 to 13.26
|
14.81 Percentage of Participants
Interval 10.75 to 18.88
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 42 (n=44,47,41)
|
19.59 Percentage of Participants
Interval 15.3 to 23.88
|
15.19 Percentage of Participants
Interval 11.26 to 19.12
|
18.69 Percentage of Participants
Interval 14.2 to 23.18
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 48 (n=43,44,38)
|
21.42 Percentage of Participants
Interval 16.96 to 25.88
|
18.84 Percentage of Participants
Interval 14.52 to 23.16
|
18.69 Percentage of Participants
Interval 14.2 to 23.18
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 54 (n=41,44,36)
|
23.25 Percentage of Participants
Interval 18.63 to 27.86
|
18.84 Percentage of Participants
Interval 14.52 to 23.16
|
18.69 Percentage of Participants
Interval 14.2 to 23.18
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 60 (n=41,44,35)
|
23.25 Percentage of Participants
Interval 18.63 to 27.86
|
18.84 Percentage of Participants
Interval 14.52 to 23.16
|
20.95 Percentage of Participants
Interval 16.2 to 25.7
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 66 (n=39,42,29)
|
23.25 Percentage of Participants
Interval 18.63 to 27.86
|
18.84 Percentage of Participants
Interval 14.52 to 23.16
|
20.95 Percentage of Participants
Interval 16.2 to 25.7
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 72 (n=35,28,19)
|
23.25 Percentage of Participants
Interval 18.63 to 27.86
|
22.81 Percentage of Participants
Interval 18.1 to 27.51
|
20.95 Percentage of Participants
Interval 16.2 to 25.7
|
SECONDARY outcome
Timeframe: Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72Population: FAS. n is the number of participants remaining at risk at each visit.
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 was 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. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.
Outcome measures
| Measure |
Cyclosporine
n=54 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=52 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=48 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Kaplan-Meier Analysis of Percentage of Participants With Combined Banff Rejection by Visit
Month 12
|
15.63 Percentage of Participants
Interval 11.81 to 19.44
|
13.33 Percentage of Participants
Interval 9.64 to 17.03
|
11.11 Percentage of Participants
Interval 7.51 to 14.71
|
|
Kaplan-Meier Analysis of Percentage of Participants With Combined Banff Rejection by Visit
Month 15 (n=51,52,45)
|
20.31 Percentage of Participants
Interval 16.08 to 24.55
|
13.33 Percentage of Participants
Interval 9.64 to 17.03
|
16.67 Percentage of Participants
Interval 12.4 to 20.93
|
|
Kaplan-Meier Analysis of Percentage of Participants With Combined Banff Rejection by Visit
Month 18 (n=49,52,43)
|
21.91 Percentage of Participants
Interval 17.55 to 26.26
|
13.33 Percentage of Participants
Interval 9.64 to 17.03
|
16.67 Percentage of Participants
Interval 12.4 to 20.93
|
|
Kaplan-Meier Analysis of Percentage of Participants With Combined Banff Rejection by Visit
Month 24 (n=46,50,37)
|
23.57 Percentage of Participants
Interval 19.09 to 28.05
|
15.00 Percentage of Participants
Interval 11.12 to 18.88
|
18.60 Percentage of Participants
Interval 14.13 to 23.07
|
|
Kaplan-Meier Analysis of Percentage of Participants With Combined Banff Rejection by Visit
Month 30 (n=44,37,23)
|
23.57 Percentage of Participants
Interval 19.09 to 28.05
|
15.00 Percentage of Participants
Interval 11.12 to 18.88
|
21.41 Percentage of Participants
Interval 16.51 to 26.31
|
|
Kaplan-Meier Analysis of Percentage of Participants With Combined Banff Rejection by Visit
Month 36 (n=41,28,12)
|
25.30 Percentage of Participants
Interval 20.69 to 29.92
|
15.00 Percentage of Participants
Interval 11.12 to 18.88
|
21.41 Percentage of Participants
Interval 16.51 to 26.31
|
|
Kaplan-Meier Analysis of Percentage of Participants With Combined Banff Rejection by Visit
Month 42 (n=34,28,11)
|
27.44 Percentage of Participants
Interval 22.62 to 32.26
|
15.00 Percentage of Participants
Interval 11.12 to 18.88
|
21.41 Percentage of Participants
Interval 16.51 to 26.31
|
|
Kaplan-Meier Analysis of Percentage of Participants With Combined Banff Rejection by Visit
Month 48 (n=33,28,11)
|
27.44 Percentage of Participants
Interval 22.62 to 32.26
|
15.00 Percentage of Participants
Interval 11.12 to 18.88
|
21.41 Percentage of Participants
Interval 16.51 to 26.31
|
|
Kaplan-Meier Analysis of Percentage of Participants With Combined Banff Rejection by Visit
Month 54 (n=33,27,10)
|
27.44 Percentage of Participants
Interval 22.62 to 32.26
|
15.00 Percentage of Participants
Interval 11.12 to 18.88
|
21.41 Percentage of Participants
Interval 16.51 to 26.31
|
|
Kaplan-Meier Analysis of Percentage of Participants With Combined Banff Rejection by Visit
Month 60 (n=31,23,9)
|
27.44 Percentage of Participants
Interval 22.62 to 32.26
|
15.00 Percentage of Participants
Interval 11.12 to 18.88
|
21.41 Percentage of Participants
Interval 16.51 to 26.31
|
|
Kaplan-Meier Analysis of Percentage of Participants With Combined Banff Rejection by Visit
Month 66 (n=26,20,9)
|
27.44 Percentage of Participants
Interval 22.62 to 32.26
|
15.00 Percentage of Participants
Interval 11.12 to 18.88
|
21.41 Percentage of Participants
Interval 16.51 to 26.31
|
|
Kaplan-Meier Analysis of Percentage of Participants With Combined Banff Rejection by Visit
Month 72 (n=24,18,9)
|
27.44 Percentage of Participants
Interval 22.62 to 32.26
|
15.00 Percentage of Participants
Interval 11.12 to 18.88
|
21.41 Percentage of Participants
Interval 16.51 to 26.31
|
SECONDARY outcome
Timeframe: Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72Population: FAS. n is the number of participants remaining at risk at each visit.
Graft loss was defined as graft nephrectomy, subject death, retransplantation, or return to dialysis for at least 6 consecutive weeks. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. Included data up to 2 months postdose in the clinical Follow-up visit.
Outcome measures
| Measure |
Cyclosporine
n=64 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=60 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=54 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Kaplan-Meier Analysis of Percent of Participants With Graft Survival With Death Censored by Visit
Month 12
|
100.00 Percentage of participants
Interval 99.58 to 100.0
|
100.00 Percentage of participants
Interval 98.48 to 100.0
|
100.00 Percentage of participants
Interval 98.32 to 100.0
|
|
Kaplan-Meier Analysis of Percent of Participants With Graft Survival With Death Censored by Visit
Month 42 (n=46,32,15)
|
96.48 Percentage of participants
Interval 94.43 to 98.54
|
100.00 Percentage of participants
Interval 97.18 to 100.0
|
100.00 Percentage of participants
Interval 94.07 to 100.0
|
|
Kaplan-Meier Analysis of Percent of Participants With Graft Survival With Death Censored by Visit
Month 15
|
100.00 Percentage of participants
Interval 95.58 to 100.0
|
100.00 Percentage of participants
Interval 98.48 to 100.0
|
100.00 Percentage of participants
Interval 98.32 to 100.0
|
|
Kaplan-Meier Analysis of Percent of Participants With Graft Survival With Death Censored by Visit
Month 18 (n=62,59,51)
|
100.00 Percentage of participants
Interval 98.53 to 100.0
|
100.00 Percentage of participants
Interval 98.46 to 100.0
|
100.00 Percentage of participants
Interval 98.22 to 100.0
|
|
Kaplan-Meier Analysis of Percent of Participants With Graft Survival With Death Censored by Visit
Month 30 (n=55,42,31)
|
98.31 Percentage of participants
Interval 96.89 to 99.72
|
100.00 Percentage of participants
Interval 97.84 to 100.0
|
100.00 Percentage of participants
Interval 97.09 to 100.0
|
|
Kaplan-Meier Analysis of Percent of Participants With Graft Survival With Death Censored by Visit
Month 24 (n=59,58,45)
|
100.00 Percentage of participants
Interval 98.46 to 100.0
|
100.00 Percentage of participants
Interval 98.43 to 100.0
|
100.00 Percentage of participants
Interval 97.98 to 100.0
|
|
Kaplan-Meier Analysis of Percent of Participants With Graft Survival With Death Censored by Visit
Month 36 (n=53,32,16)
|
96.48 Percentage of participants
Interval 94.43 to 98.54
|
100.00 Percentage of participants
Interval 97.18 to 100.0
|
100.00 Percentage of participants
Interval 94.43 to 100.0
|
|
Kaplan-Meier Analysis of Percent of Participants With Graft Survival With Death Censored by Visit
Month 48 (n=44,32,15)
|
96.48 Percentage of participants
Interval 94.43 to 98.54
|
100.00 Percentage of participants
Interval 97.18 to 100.0
|
100.00 Percentage of participants
Interval 94.07 to 100.0
|
|
Kaplan-Meier Analysis of Percent of Participants With Graft Survival With Death Censored by Visit
Month 54 (n=43,31,14)
|
96.48 Percentage of participants
Interval 94.43 to 98.54
|
100.00 Percentage of participants
Interval 97.09 to 100.0
|
100.00 Percentage of participants
Interval 93.66 to 100.0
|
|
Kaplan-Meier Analysis of Percent of Participants With Graft Survival With Death Censored by Visit
Month 60 (n=40,26,13)
|
96.48 Percentage of participants
Interval 94.43 to 98.54
|
100.00 Percentage of participants
Interval 96.54 to 100.0
|
100.00 Percentage of participants
Interval 93.19 to 100.0
|
|
Kaplan-Meier Analysis of Percent of Participants With Graft Survival With Death Censored by Visit
Month 66 (n=35,23,11)
|
96.48 Percentage of participants
Interval 94.43 to 98.54
|
100.00 Percentage of participants
Interval 96.09 to 100.0
|
100.00 Percentage of participants
Interval 92.01 to 100.0
|
|
Kaplan-Meier Analysis of Percent of Participants With Graft Survival With Death Censored by Visit
Month 72 (n=31,20,11)
|
96.48 Percentage of participants
Interval 94.43 to 98.54
|
100.00 Percentage of participants
Interval 95.52 to 100.0
|
100.00 Percentage of participants
Interval 92.01 to 100.0
|
SECONDARY outcome
Timeframe: Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72Population: FAS. n is the number of participants remaining at risk at each visit.
The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. Included data up to 2 months postdose in the clinical Follow-up visit.
Outcome measures
| Measure |
Cyclosporine
n=64 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=60 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=54 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 12
|
100.00 Percentage of Participants
Interval 98.58 to 100.0
|
100.00 Percentage of Participants
Interval 98.48 to 100.0
|
100.00 Percentage of Participants
Interval 98.32 to 100.0
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 15 (n=64,60,53)
|
100.00 Percentage of Participants
Interval 98.58 to 100.0
|
100.00 Percentage of Participants
Interval 98.48 to 100.0
|
98.15 Percentage of Participants
Interval 96.6 to 99.69
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 18 (n=61,59,51)
|
98.41 Percentage of Participants
Interval 97.09 to 99.74
|
100.00 Percentage of Participants
Interval 98.46 to 100.0
|
98.15 Percentage of Participants
Interval 96.6 to 99.69
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 24 (n=59,58,44)
|
98.41 Percentage of Participants
Interval 97.09 to 99.74
|
100.00 Percentage of Participants
Interval 98.43 to 100.0
|
94.22 Percentage of Participants
Interval 91.49 to 96.95
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 30 (n=55,42,31)
|
98.41 Percentage of Participants
Interval 97.09 to 99.74
|
100.00 Percentage of Participants
Interval 97.84 to 100.0
|
94.22 Percentage of Participants
Interval 91.49 to 96.95
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 36 (n=53,32,16)
|
98.41 Percentage of Participants
Interval 97.09 to 99.74
|
100.00 Percentage of Participants
Interval 97.18 to 100.0
|
90.97 Percentage of Participants
Interval 87.21 to 94.73
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 42 (n=45,32,15)
|
96.27 Percentage of Participants
Interval 94.07 to 98.48
|
100.00 Percentage of Participants
Interval 97.18 to 100.0
|
90.97 Percentage of Participants
Interval 87.21 to 94.73
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 48 (n=44,32,15)
|
96.27 Percentage of Participants
Interval 94.07 to 98.48
|
100.00 Percentage of Participants
Interval 97.18 to 100.0
|
90.97 Percentage of Participants
Interval 87.21 to 94.73
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 54 (n=43,31,14)
|
94.09 Percentage of Participants
Interval 91.27 to 96.9
|
100.00 Percentage of Participants
Interval 97.09 to 100.0
|
90.97 Percentage of Participants
Interval 87.21 to 94.73
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 60 (n=40,26,13)
|
94.09 Percentage of Participants
Interval 91.27 to 96.9
|
100.00 Percentage of Participants
Interval 96.54 to 100.0
|
90.97 Percentage of Participants
Interval 87.21 to 94.73
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 66 (n=35,23,11)
|
94.09 Percentage of Participants
Interval 91.27 to 96.9
|
100.00 Percentage of Participants
Interval 96.09 to 100.0
|
90.97 Percentage of Participants
Interval 87.21 to 94.73
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 72 (n=31,20,11)
|
94.09 Percentage of Participants
Interval 91.27 to 96.9
|
100.00 Percentage of Participants
Interval 95.52 to 100.0
|
90.97 Percentage of Participants
Interval 87.21 to 94.73
|
SECONDARY outcome
Timeframe: Months 12 through 72.Population: Safety Analysis Set
Discontinuations were due to any reason including those occurring as a result of protocol Amendments 3 and 4.
Outcome measures
| Measure |
Cyclosporine
n=64 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=60 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=54 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Percentage of Participants Discontinuing From the Study
|
43.8 Percentage of Participants
|
75.0 Percentage of Participants
|
85.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72Population: Safety Analysis Set. n is the number of participants with the assessment at each visit.
Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.
Outcome measures
| Measure |
Cyclosporine
n=59 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=59 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=49 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Least Squares Means of Total Serum Cholesterol Levels (Milligrams Per Deciliter [mg/dL]) by Visit
Month 60 (n=37,23,12)
|
190.10 mg/dL
Standard Error 7.17
|
220.47 mg/dL
Standard Error 8.85
|
184.14 mg/dL
Standard Error 12.53
|
|
Least Squares Means of Total Serum Cholesterol Levels (Milligrams Per Deciliter [mg/dL]) by Visit
Month 66 (n=34,20,11)
|
191.00 mg/dL
Standard Error 7.47
|
218.77 mg/dL
Standard Error 9.47
|
189.15 mg/dL
Standard Error 13.14
|
|
Least Squares Means of Total Serum Cholesterol Levels (Milligrams Per Deciliter [mg/dL]) by Visit
Month 15
|
199.14 mg/dL
Standard Error 5.71
|
213.49 mg/dL
Standard Error 5.81
|
196.27 mg/dL
Standard Error 6.29
|
|
Least Squares Means of Total Serum Cholesterol Levels (Milligrams Per Deciliter [mg/dL]) by Visit
Month 18
|
200.51 mg/dL
Standard Error 5.75
|
212.67 mg/dL
Standard Error 5.82
|
193.50 mg/dL
Standard Error 6.34
|
|
Least Squares Means of Total Serum Cholesterol Levels (Milligrams Per Deciliter [mg/dL]) by Visit
Month 24 (n=58,54,40)
|
198.78 mg/dL
Standard Error 5.82
|
212.30 mg/dL
Standard Error 5.98
|
185.57 mg/dL
Standard Error 6.80
|
|
Least Squares Means of Total Serum Cholesterol Levels (Milligrams Per Deciliter [mg/dL]) by Visit
Month 30 (n=52,37,26)
|
193.99 mg/dL
Standard Error 6.05
|
211.59 mg/dL
Standard Error 6.84
|
202.73 mg/dL
Standard Error 8.08
|
|
Least Squares Means of Total Serum Cholesterol Levels (Milligrams Per Deciliter [mg/dL]) by Visit
Month 36 (n=51,32,15)
|
198.62 mg/dL
Standard Error 6.17
|
211.14 mg/dL
Standard Error 7.51
|
192.97 mg/dL
Standard Error 10.37
|
|
Least Squares Means of Total Serum Cholesterol Levels (Milligrams Per Deciliter [mg/dL]) by Visit
Month 42 (n=44,31,15)
|
200.36 mg/dL
Standard Error 6.52
|
220.29 mg/dL
Standard Error 7.83
|
208.77 mg/dL
Standard Error 11.13
|
|
Least Squares Means of Total Serum Cholesterol Levels (Milligrams Per Deciliter [mg/dL]) by Visit
Month 48 (n=42,30,14)
|
196.56 mg/dL
Standard Error 6.74
|
228.83 mg/dL
Standard Error 7.98
|
188.83 mg/dL
Standard Error 11.66
|
|
Least Squares Means of Total Serum Cholesterol Levels (Milligrams Per Deciliter [mg/dL]) by Visit
Month 54 (n=41,31,13)
|
193.66 mg/dL
Standard Error 6.87
|
222.86 mg/dL
Standard Error 7.98
|
183.17 mg/dL
Standard Error 12.06
|
|
Least Squares Means of Total Serum Cholesterol Levels (Milligrams Per Deciliter [mg/dL]) by Visit
Month 72 (n=31,17,11)
|
188.74 mg/dL
Standard Error 7.82
|
209.12 mg/dL
Standard Error 10.26
|
182.60 mg/dL
Standard Error 13.36
|
SECONDARY outcome
Timeframe: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72Population: Safety Analysis Set. n is the number of participants with the assessment at each visit.
Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.
Outcome measures
| Measure |
Cyclosporine
n=56 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=54 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=49 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Least Squares Means of Total Serum Low Density Lipoprotein (LDL) Cholesterol Levels (mg/dL) by Visit
Month 60 (n=36,21,12)
|
105.37 mg/dL
Standard Error 5.66
|
123.71 mg/dL
Standard Error 7.18
|
97.79 mg/dL
Standard Error 9.75
|
|
Least Squares Means of Total Serum Low Density Lipoprotein (LDL) Cholesterol Levels (mg/dL) by Visit
Month 15 (n=54,54,48)
|
113.09 mg/dL
Standard Error 4.60
|
119.71 mg/dL
Standard Error 4.68
|
108.72 mg/dL
Standard Error 4.94
|
|
Least Squares Means of Total Serum Low Density Lipoprotein (LDL) Cholesterol Levels (mg/dL) by Visit
Month 18
|
112.82 mg/dL
Standard Error 4.58
|
119.36 mg/dL
Standard Error 4.69
|
109.87 mg/dL
Standard Error 4.94
|
|
Least Squares Means of Total Serum Low Density Lipoprotein (LDL) Cholesterol Levels (mg/dL) by Visit
Month 24 (n=55,49,40)
|
111.14 mg/dL
Standard Error 4.64
|
119.15 mg/dL
Standard Error 4.83
|
104.63 mg/dL
Standard Error 5.29
|
|
Least Squares Means of Total Serum Low Density Lipoprotein (LDL) Cholesterol Levels (mg/dL) by Visit
Month 30 (n=49,36,25)
|
106.79 mg/dL
Standard Error 4.84
|
125.24 mg/dL
Standard Error 5.43
|
112.44 mg/dL
Standard Error 6.36
|
|
Least Squares Means of Total Serum Low Density Lipoprotein (LDL) Cholesterol Levels (mg/dL) by Visit
Month 36 (n=47,31,15)
|
112.81 mg/dL
Standard Error 4.97
|
123.27 mg/dL
Standard Error 5.95
|
109.54 mg/dL
Standard Error 8.10
|
|
Least Squares Means of Total Serum Low Density Lipoprotein (LDL) Cholesterol Levels (mg/dL) by Visit
Month 42 (n=42,27,15)
|
110.98 mg/dL
Standard Error 5.21
|
122.51 mg/dL
Standard Error 6.39
|
121.74 mg/dL
Standard Error 8.67
|
|
Least Squares Means of Total Serum Low Density Lipoprotein (LDL) Cholesterol Levels (mg/dL) by Visit
Month 48 (n=41,27,14)
|
109.03 mg/dL
Standard Error 5.35
|
127.65 mg/dL
Standard Error 6.48
|
105.59 mg/dL
Standard Error 9.08
|
|
Least Squares Means of Total Serum Low Density Lipoprotein (LDL) Cholesterol Levels (mg/dL) by Visit
Month 54 (n=40,28,13)
|
107.21 mg/dL
Standard Error 5.44
|
128.39 mg/dL
Standard Error 6.45
|
96.60 mg/dL
Standard Error 9.39
|
|
Least Squares Means of Total Serum Low Density Lipoprotein (LDL) Cholesterol Levels (mg/dL) by Visit
Month 66 (n=32,19,11)
|
104.31 mg/dL
Standard Error 5.95
|
123.74 mg/dL
Standard Error 7.64
|
102.44 mg/dL
Standard Error 10.23
|
|
Least Squares Means of Total Serum Low Density Lipoprotein (LDL) Cholesterol Levels (mg/dL) by Visit
Month 72 (n=30,16,11)
|
109.18 mg/dL
Standard Error 6.19
|
116.17 mg/dL
Standard Error 8.27
|
96.11 mg/dL
Standard Error 10.40
|
SECONDARY outcome
Timeframe: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72Population: Safety Analysis Set. n is the number of participants with the assessment at each visit.
Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.
Outcome measures
| Measure |
Cyclosporine
n=59 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=59 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=49 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Least Squares Means of Total Serum High Density Lipoprotein (HDL) Cholesterol Levels (mg/dL) by Visit
Month 15
|
49.88 mg/dL
Standard Error 1.75
|
59.67 mg/dL
Standard Error 1.79
|
55.20 mg/dL
Standard Error 1.93
|
|
Least Squares Means of Total Serum High Density Lipoprotein (HDL) Cholesterol Levels (mg/dL) by Visit
Month 18
|
50.47 mg/dL
Standard Error 1.77
|
59.87 mg/dL
Standard Error 1.79
|
55.78 mg/dL
Standard Error 1.95
|
|
Least Squares Means of Total Serum High Density Lipoprotein (HDL) Cholesterol Levels (mg/dL) by Visit
Month 24 (n=58,54,40)
|
51.47 mg/dL
Standard Error 1.79
|
59.84 mg/dL
Standard Error 1.84
|
53.52 mg/dL
Standard Error 2.08
|
|
Least Squares Means of Total Serum High Density Lipoprotein (HDL) Cholesterol Levels (mg/dL) by Visit
Month 30 (n=52,37,26)
|
49.55 mg/dL
Standard Error 1.85
|
60.45 mg/dL
Standard Error 2.10
|
53.84 mg/dL
Standard Error 2.47
|
|
Least Squares Means of Total Serum High Density Lipoprotein (HDL) Cholesterol Levels (mg/dL) by Visit
Month 36 (n=51,32,15)
|
50.46 mg/dL
Standard Error 1.89
|
59.92 mg/dL
Standard Error 2.30
|
54.59 mg/dL
Standard Error 3.17
|
|
Least Squares Means of Total Serum High Density Lipoprotein (HDL) Cholesterol Levels (mg/dL) by Visit
Month 42 (n=44,31,15)
|
53.24 mg/dL
Standard Error 2.00
|
59.32 mg/dL
Standard Error 2.40
|
58.59 mg/dL
Standard Error 3.41
|
|
Least Squares Means of Total Serum High Density Lipoprotein (HDL) Cholesterol Levels (mg/dL) by Visit
Month 48 (n=42,30,14)
|
54.59 mg/dL
Standard Error 2.07
|
61.67 mg/dL
Standard Error 2.45
|
53.55 mg/dL
Standard Error 3.57
|
|
Least Squares Means of Total Serum High Density Lipoprotein (HDL) Cholesterol Levels (mg/dL) by Visit
Month 54 (n=41,31,13)
|
54.55 mg/dL
Standard Error 2.11
|
60.18 mg/dL
Standard Error 2.45
|
52.38 mg/dL
Standard Error 3.70
|
|
Least Squares Means of Total Serum High Density Lipoprotein (HDL) Cholesterol Levels (mg/dL) by Visit
Month 60 (n=37,23,12)
|
54.72 mg/dL
Standard Error 2.20
|
60.20 mg/dL
Standard Error 2.71
|
58.98 mg/dL
Standard Error 3.84
|
|
Least Squares Means of Total Serum High Density Lipoprotein (HDL) Cholesterol Levels (mg/dL) by Visit
Month 66 (n=34,20,11)
|
54.69 mg/dL
Standard Error 2.29
|
62.12 mg/dL
Standard Error 2.90
|
56.08 mg/dL
Standard Error 4.03
|
|
Least Squares Means of Total Serum High Density Lipoprotein (HDL) Cholesterol Levels (mg/dL) by Visit
Month 72 (31,17,11)
|
52.80 mg/dL
Standard Error 2.40
|
58.80 mg/dL
Standard Error 3.14
|
54.93 mg/dL
Standard Error 4.10
|
SECONDARY outcome
Timeframe: Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72Population: Safety Population. n is the number of participants with the assessment at each visit.
Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.
Outcome measures
| Measure |
Cyclosporine
n=59 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=59 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=49 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Least Squares Means of Total Serum Triglycerides (mg/dL) by Visit
Month 42 (n=44,31,15)
|
178.93 mg/dL
Standard Error 15.55
|
183.09 mg/dL
Standard Error 18.64
|
148.62 mg/dL
Standard Error 26.42
|
|
Least Squares Means of Total Serum Triglycerides (mg/dL) by Visit
Month 48 (n=42,30,14)
|
166.38 mg/dL
Standard Error 16.08
|
196.86 mg/dL
Standard Error 19.04
|
156.12 mg/dL
Standard Error 27.76
|
|
Least Squares Means of Total Serum Triglycerides (mg/dL) by Visit
Month 54 (n=41,31,13)
|
163.57 mg/dL
Standard Error 16.41
|
169.18 mg/dL
Standard Error 19.07
|
178.24 mg/dL
Standard Error 28.75
|
|
Least Squares Means of Total Serum Triglycerides (mg/dL) by Visit
Month 60 (n=37,23,12)
|
156.27 mg/dL
Standard Error 17.10
|
173.20 mg/dL
Standard Error 21.06
|
142.27 mg/dL
Standard Error 29.89
|
|
Least Squares Means of Total Serum Triglycerides (mg/dL) by Visit
Month 66 (n=34,20,11)
|
165.83 mg/dL
Standard Error 17.82
|
174.19 mg/dL
Standard Error 22.54
|
158.73 mg/dL
Standard Error 31.35
|
|
Least Squares Means of Total Serum Triglycerides (mg/dL) by Visit
Month 72 (n=31,17,11)
|
143.03 mg/dL
Standard Error 18.63
|
165.10 mg/dL
Standard Error 24.40
|
161.28 mg/dL
Standard Error 31.94
|
|
Least Squares Means of Total Serum Triglycerides (mg/dL) by Visit
Month 15
|
177.33 mg/dL
Standard Error 13.66
|
171.21 mg/dL
Standard Error 13.94
|
167.38 mg/dL
Standard Error 15.07
|
|
Least Squares Means of Total Serum Triglycerides (mg/dL) by Visit
Month 18
|
181.92 mg/dL
Standard Error 13.74
|
163.26 mg/dL
Standard Error 13.97
|
145.05 mg/dL
Standard Error 15.18
|
|
Least Squares Means of Total Serum Triglycerides (mg/dL) by Visit
Month 24 (n=58,54,40)
|
183.79 mg/dL
Standard Error 13.93
|
162.80 mg/dL
Standard Error 14.33
|
142.07 mg/dL
Standard Error 16.23
|
|
Least Squares Means of Total Serum Triglycerides (mg/dL) by Visit
Month 30 (n=52,37,26)
|
182.49 mg/dL
Standard Error 14.44
|
137.05 mg/dL
Standard Error 16.28
|
178.56 mg/dL
Standard Error 19.18
|
|
Least Squares Means of Total Serum Triglycerides (mg/dL) by Visit
Month 36 (n=51,32,15)
|
174.01 mg/dL
Standard Error 14.73
|
145.27 mg/dL
Standard Error 17.85
|
152.98 mg/dL
Standard Error 24.50
|
SECONDARY outcome
Timeframe: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-upPopulation: Safety Analysis Set. n is the number of participants with the assessment at each visit.
Follow-up visit included Month 74 visit for completers and 2-month postdose visit for early withdrawals.
Outcome measures
| Measure |
Cyclosporine
n=59 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=58 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=49 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Mean Absolute Neutrophil Counts (ANC) (Kelvin Per Millimeter Cubed [K/mm^3]) by Visit
Month 15 (n=55,56,47)
|
4.53 k/mm^3
Standard Deviation 1.82
|
4.23 k/mm^3
Standard Deviation 1.79
|
4.33 k/mm^3
Standard Deviation 1.76
|
|
Mean Absolute Neutrophil Counts (ANC) (Kelvin Per Millimeter Cubed [K/mm^3]) by Visit
Month 18
|
4.59 k/mm^3
Standard Deviation 1.98
|
3.87 k/mm^3
Standard Deviation 1.57
|
4.83 k/mm^3
Standard Deviation 2.84
|
|
Mean Absolute Neutrophil Counts (ANC) (Kelvin Per Millimeter Cubed [K/mm^3]) by Visit
Month 24 (n=54,52,39)
|
4.62 k/mm^3
Standard Deviation 1.93
|
3.99 k/mm^3
Standard Deviation 1.43
|
4.38 k/mm^3
Standard Deviation 1.55
|
|
Mean Absolute Neutrophil Counts (ANC) (Kelvin Per Millimeter Cubed [K/mm^3]) by Visit
Month 30 (n=48,35,26)
|
4.69 k/mm^3
Standard Deviation 1.91
|
3.48 k/mm^3
Standard Deviation 1.25
|
4.55 k/mm^3
Standard Deviation 1.71
|
|
Mean Absolute Neutrophil Counts (ANC) (Kelvin Per Millimeter Cubed [K/mm^3]) by Visit
Month 36 (n=51,30,15)
|
4.48 k/mm^3
Standard Deviation 1.93
|
3.72 k/mm^3
Standard Deviation 1.41
|
4.62 k/mm^3
Standard Deviation 1.22
|
|
Mean Absolute Neutrophil Counts (ANC) (Kelvin Per Millimeter Cubed [K/mm^3]) by Visit
Month 42 (n=40,31,15)
|
4.30 k/mm^3
Standard Deviation 1.80
|
3.90 k/mm^3
Standard Deviation 1.76
|
4.49 k/mm^3
Standard Deviation 0.81
|
|
Mean Absolute Neutrophil Counts (ANC) (Kelvin Per Millimeter Cubed [K/mm^3]) by Visit
Month 48 (n=41,30,13)
|
3.86 k/mm^3
Standard Deviation 1.93
|
3.47 k/mm^3
Standard Deviation 1.58
|
3.86 k/mm^3
Standard Deviation 1.59
|
|
Mean Absolute Neutrophil Counts (ANC) (Kelvin Per Millimeter Cubed [K/mm^3]) by Visit
Month 54 (n=38,26,11)
|
4.11 k/mm^3
Standard Deviation 1.78
|
3.42 k/mm^3
Standard Deviation 1.09
|
4.27 k/mm^3
Standard Deviation 1.52
|
|
Mean Absolute Neutrophil Counts (ANC) (Kelvin Per Millimeter Cubed [K/mm^3]) by Visit
Month 60 (n=37,20,11)
|
4.30 k/mm^3
Standard Deviation 1.80
|
3.97 k/mm^3
Standard Deviation 1.57
|
4.01 k/mm^3
Standard Deviation 1.24
|
|
Mean Absolute Neutrophil Counts (ANC) (Kelvin Per Millimeter Cubed [K/mm^3]) by Visit
Month 66 (n=34,19,11)
|
4.53 k/mm^3
Standard Deviation 1.85
|
3.86 k/mm^3
Standard Deviation 1.51
|
4.28 k/mm^3
Standard Deviation 1.21
|
|
Mean Absolute Neutrophil Counts (ANC) (Kelvin Per Millimeter Cubed [K/mm^3]) by Visit
Month 72 (n=31,17,11)
|
4.33 k/mm^3
Standard Deviation 1.85
|
3.44 k/mm^3
Standard Deviation 1.12
|
4.73 k/mm^3
Standard Deviation 1.47
|
|
Mean Absolute Neutrophil Counts (ANC) (Kelvin Per Millimeter Cubed [K/mm^3]) by Visit
Follow-up (n=51,46,41)
|
4.65 k/mm^3
Standard Deviation 1.77
|
3.75 k/mm^3
Standard Deviation 1.26
|
4.37 k/mm^3
Standard Deviation 1.97
|
SECONDARY outcome
Timeframe: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-upPopulation: Safety Analysis Set. n is the number of participants with the assessment at each visit.
Follow-up visit included Month 74 visit for completers and 2-month postdose visit for early withdrawals.
Outcome measures
| Measure |
Cyclosporine
n=59 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=59 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=49 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Mean Hemoglobin (Hgb) (Grams Per Deciliter [g/dL]) by Visit
Month 18
|
13.15 g/dL
Standard Deviation 1.71
|
13.31 g/dL
Standard Deviation 1.13
|
13.50 g/dL
Standard Deviation 1.86
|
|
Mean Hemoglobin (Hgb) (Grams Per Deciliter [g/dL]) by Visit
Follow-up (n=51,47,41)
|
12.49 g/dL
Standard Deviation 2.04
|
13.23 g/dL
Standard Deviation 1.75
|
13.72 g/dL
Standard Deviation 2.09
|
|
Mean Hemoglobin (Hgb) (Grams Per Deciliter [g/dL]) by Visit
Month 15 (n=58,59,48)
|
13.20 g/dL
Standard Deviation 1.78
|
13.14 g/dL
Standard Deviation 1.41
|
13.35 g/dL
Standard Deviation 1.65
|
|
Mean Hemoglobin (Hgb) (Grams Per Deciliter [g/dL]) by Visit
Month 24 (n=57,54,41)
|
13.35 g/dL
Standard Deviation 1.58
|
13.58 g/dL
Standard Deviation 1.25
|
13.58 g/dL
Standard Deviation 1.54
|
|
Mean Hemoglobin (Hgb) (Grams Per Deciliter [g/dL]) by Visit
Month 30 (n=48,37,28)
|
13.21 g/dL
Standard Deviation 1.66
|
13.66 g/dL
Standard Deviation 1.23
|
13.82 g/dL
Standard Deviation 1.60
|
|
Mean Hemoglobin (Hgb) (Grams Per Deciliter [g/dL]) by Visit
Month 36 (n=52,32,15)
|
13.30 g/dL
Standard Deviation 1.59
|
13.91 g/dL
Standard Deviation 1.08
|
13.44 g/dL
Standard Deviation 1.94
|
|
Mean Hemoglobin (Hgb) (Grams Per Deciliter [g/dL]) by Visit
Month 42 (n=41,31,15)
|
13.24 g/dL
Standard Deviation 1.60
|
13.99 g/dL
Standard Deviation 0.99
|
13.67 g/dL
Standard Deviation 1.70
|
|
Mean Hemoglobin (Hgb) (Grams Per Deciliter [g/dL]) by Visit
Month 48 (n=42,31,13)
|
13.05 g/dL
Standard Deviation 1.71
|
14.01 g/dL
Standard Deviation 1.18
|
13.28 g/dL
Standard Deviation 1.45
|
|
Mean Hemoglobin (Hgb) (Grams Per Deciliter [g/dL]) by Visit
Month 54 (n=40,29,11)
|
13.22 g/dL
Standard Deviation 1.53
|
13.98 g/dL
Standard Deviation 1.31
|
13.60 g/dL
Standard Deviation 1.54
|
|
Mean Hemoglobin (Hgb) (Grams Per Deciliter [g/dL]) by Visit
Month 60 (n=37,20,12)
|
13.29 g/dL
Standard Deviation 1.56
|
14.40 g/dL
Standard Deviation 1.24
|
13.41 g/dL
Standard Deviation 1.94
|
|
Mean Hemoglobin (Hgb) (Grams Per Deciliter [g/dL]) by Visit
Month 66 (n=34,19,11)
|
13.02 g/dL
Standard Deviation 1.88
|
14.62 g/dL
Standard Deviation 1.18
|
13.42 g/dL
Standard Deviation 2.14
|
|
Mean Hemoglobin (Hgb) (Grams Per Deciliter [g/dL]) by Visit
Month 72 (n=31,17,11)
|
13.10 g/dL
Standard Deviation 1.84
|
14.22 g/dL
Standard Deviation 1.56
|
13.23 g/dL
Standard Deviation 2.03
|
SECONDARY outcome
Timeframe: Months 24, 36, 48, 60, 72Population: Safety Analysis Set. n is the number of participants with the assessment at each visit.
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.
Outcome measures
| Measure |
Cyclosporine
n=55 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=51 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=35 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Mean Glycosylated Hemoglobin (HBA1c) (Percent [%]) by Visit
Month 72 (n=31,16,11)
|
6.52 Percentage
Standard Deviation 1.98
|
6.34 Percentage
Standard Deviation 1.57
|
6.33 Percentage
Standard Deviation 2.21
|
|
Mean Glycosylated Hemoglobin (HBA1c) (Percent [%]) by Visit
Month 24
|
6.35 Percentage
Standard Deviation 1.84
|
6.16 Percentage
Standard Deviation 1.53
|
6.37 Percentage
Standard Deviation 1.40
|
|
Mean Glycosylated Hemoglobin (HBA1c) (Percent [%]) by Visit
Month 36 (n=50,32,15)
|
6.16 Percentage
Standard Deviation 1.39
|
5.92 Percentage
Standard Deviation 1.20
|
6.69 Percentage
Standard Deviation 2.31
|
|
Mean Glycosylated Hemoglobin (HBA1c) (Percent [%]) by Visit
Month 48 (n=43,31,14)
|
6.15 Percentage
Standard Deviation 1.64
|
6.16 Percentage
Standard Deviation 1.88
|
6.59 Percentage
Standard Deviation 1.71
|
|
Mean Glycosylated Hemoglobin (HBA1c) (Percent [%]) by Visit
Month 60 (n=37,23,12)
|
6.36 Percentage
Standard Deviation 1.94
|
6.26 Percentage
Standard Deviation 2.03
|
6.28 Percentage
Standard Deviation 1.88
|
SECONDARY outcome
Timeframe: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72Population: Safety Population. n is the number of participants with the assessment at each visit.
Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A compund symmetry variance-covariance structure was used.
Outcome measures
| Measure |
Cyclosporine
n=59 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=59 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=49 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Least Squares Means of Fasting Serum Glucose Levels (mg/dL) by Visit
Month 15 (n=59,58,49)
|
104.42 mg/dL
Standard Error 5.56
|
102.10 mg/dL
Standard Error 5.66
|
107.18 mg/dL
Standard Error 6.13
|
|
Least Squares Means of Fasting Serum Glucose Levels (mg/dL) by Visit
Month 36 (n=51,32,15)
|
95.88 mg/dL
Standard Error 5.84
|
106.27 mg/dL
Standard Error 6.95
|
106.03 mg/dL
Standard Error 9.55
|
|
Least Squares Means of Fasting Serum Glucose Levels (mg/dL) by Visit
Month 18
|
113.01 mg/dL
Standard Error 5.57
|
106.17 mg/dL
Standard Error 5.63
|
107.56 mg/dL
Standard Error 6.13
|
|
Least Squares Means of Fasting Serum Glucose Levels (mg/dL) by Visit
Month 24 (n=58,54,41)
|
112.23 mg/dL
Standard Error 5.60
|
107.81 mg/dL
Standard Error 5.79
|
102.47 mg/dL
Standard Error 6.50
|
|
Least Squares Means of Fasting Serum Glucose Levels (mg/dL) by Visit
Month 30 (n=50,38,27)
|
105.27 mg/dL
Standard Error 5.87
|
108.01 mg/dL
Standard Error 6.53
|
107.70 mg/dL
Standard Error 7.55
|
|
Least Squares Means of Fasting Serum Glucose Levels (mg/dL) by Visit
Month 42 (n=44,31,15)
|
107.10 mg/dL
Standard Error 6.14
|
114.43 mg/dL
Standard Error 7.03
|
94.16 mg/dL
Standard Error 9.55
|
|
Least Squares Means of Fasting Serum Glucose Levels (mg/dL) by Visit
Month 48 (n=42,30,14)
|
101.14 mg/dL
Standard Error 6.23
|
109.86 mg/dL
Standard Error 7.12
|
104.07 mg/dL
Standard Error 9.83
|
|
Least Squares Means of Fasting Serum Glucose Levels (mg/dL) by Visit
Month 54 (n=41,31,13)
|
114.50 mg/dL
Standard Error 6.29
|
110.62 mg/dL
Standard Error 7.04
|
127.38 mg/dL
Standard Error 10.13
|
|
Least Squares Means of Fasting Serum Glucose Levels (mg/dL) by Visit
Month 60 (n=37,23,12)
|
109.75 mg/dL
Standard Error 6.52
|
106.64 mg/dL
Standard Error 7.88
|
107.49 mg/dL
Standard Error 10.49
|
|
Least Squares Means of Fasting Serum Glucose Levels (mg/dL) by Visit
Month 66 (n=34,20,11)
|
104.42 mg/dL
Standard Error 6.72
|
103.25 mg/dL
Standard Error 8.33
|
108.55 mg/dL
Standard Error 10.88
|
|
Least Squares Means of Fasting Serum Glucose Levels (mg/dL) by Visit
Month 72 (n=30,17,11)
|
107.01 mg/dL
Standard Error 7.04
|
105.22 mg/dL
Standard Error 8.89
|
99.82 mg/dL
Standard Error 10.88
|
SECONDARY outcome
Timeframe: Months 24, 36, 48, 60, 72 and Follow-upPopulation: Safety Analysis Set. n is the number of participants with the assessment at each visit.
Proteinuria was defined as the presence of an excess of serum proteins in the urine. Normal value of proteinuria is below 0.15 grams per 24 hours (g/24 hr). Follow-up visit included Month 74 visit for completers and 2-month postdose visit for early withdrawals.
Outcome measures
| Measure |
Cyclosporine
n=51 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=47 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=36 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Percentage of Participants by Proteinuria Category by Visit
Month 72: >200 mg/day (n=22,15,9)
|
9.1 Percentage of Participants
|
20.0 Percentage of Participants
|
22.2 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Follow-up: >1500 mg/day (n=46,34,39)
|
2.2 Percentage of Participants
|
5.9 Percentage of Participants
|
2.6 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Month 24: >200 mg/day
|
15.7 Percentage of Participants
|
27.7 Percentage of Participants
|
19.4 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Month 24: >500 mg/day
|
3.9 Percentage of Participants
|
6.4 Percentage of Participants
|
8.3 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Month 24: >1500 mg/day
|
2.0 Percentage of Participants
|
2.1 Percentage of Participants
|
5.6 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Month 24: >500 Increase from Baseline
|
2.0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Month 36: >200 mg/day (n=42,30,13)
|
14.3 Percentage of Participants
|
26.7 Percentage of Participants
|
15.4 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Month 36: >500 mg/day (n=42,30,13)
|
2.4 Percentage of Participants
|
3.3 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Month 36: >1500 mg/day (n=42,30,13)
|
2.4 Percentage of Participants
|
3.3 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Month 36: >500 Increase from Baseline (n=42,30,13)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Month 48: >200 mg/day (n=36,29,12)
|
16.7 Percentage of Participants
|
31.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Month 48: >500 mg/day (n=36,29,12)
|
5.6 Percentage of Participants
|
17.2 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Month 48: >1500 mg/day (n=36,29,12)
|
2.8 Percentage of Participants
|
6.9 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Month 48: >500 Increase in Baseline (n=36,29,12)
|
0 Percentage of Participants
|
3.4 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Month 60: >200 mg/day (n=29,20,10)
|
10.3 Percentage of Participants
|
20.0 Percentage of Participants
|
10.0 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Month 60: >500 mg/day (n=29,20,10)
|
10.3 Percentage of Participants
|
15.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Month 60: >1500 mg/day (n=29,20,10)
|
3.4 Percentage of Participants
|
5.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Month 60: >500 Increase in Baseline (n=29,20,10)
|
0 Percentage of Participants
|
5.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Month 72: >500 mg/day (n=22,15,9)
|
4.5 Percentage of Participants
|
20.0 Percentage of Participants
|
11.1 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Month 72: >1500 mg/day (n=22,15,9)
|
0 Percentage of Participants
|
13.3 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Month 72: >500 Increase in Baseline (n=22,15,9)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
11.1 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Follow-up: >200 mg/day (n=46,34,39)
|
13.0 Percentage of Participants
|
17.6 Percentage of Participants
|
20.5 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Follow-up: >500 mg/day (n=46,34,39)
|
6.5 Percentage of Participants
|
8.8 Percentage of Participants
|
5.1 Percentage of Participants
|
|
Percentage of Participants by Proteinuria Category by Visit
Follow-up: >500 Increase in Baseline (n=46,34,39)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
2.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72Population: Safety Analysis Set. n is the number of participants with the assessment at each visit.
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 Nankivell formula, where: Creatinine clearance (mL/min) = 6.7/serum creatinine (millimols per litre \[mmol/L\]) - serum urea (mmol/dL)/2 + actual body weight (kilograms \[kg\])/4 - 100/Height (metres \[m\])\^2 + (35 for male or 25 for female). A normal GFR for adults is \> 90 mL/min. Lower values indicate poor kidney function. A GFR \<15 is consistent with kidney failure. Model contained treatment, visit and treatment by visit interaction as fixed effects. An unstructured variance-covariance structure was used.
Outcome measures
| Measure |
Cyclosporine
n=59 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=59 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=50 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Least Square Means of Estimated GFR Calculated Using the Nankivell Equation by Visit
Month 60 (n=37,24,12)
|
70.08 minutes per milliliter (min/mL)
Standard Error 2.46
|
77.80 minutes per milliliter (min/mL)
Standard Error 2.77
|
74.19 minutes per milliliter (min/mL)
Standard Error 3.51
|
|
Least Square Means of Estimated GFR Calculated Using the Nankivell Equation by Visit
Month 15
|
69.57 minutes per milliliter (min/mL)
Standard Error 1.95
|
82.33 minutes per milliliter (min/mL)
Standard Error 2.00
|
82.96 minutes per milliliter (min/mL)
Standard Error 2.13
|
|
Least Square Means of Estimated GFR Calculated Using the Nankivell Equation by Visit
Month 18
|
70.93 minutes per milliliter (min/mL)
Standard Error 2.09
|
82.41 minutes per milliliter (min/mL)
Standard Error 2.15
|
82.91 minutes per milliliter (min/mL)
Standard Error 2.28
|
|
Least Square Means of Estimated GFR Calculated Using the Nankivell Equation by Visit
Month 24 (n=58,54,41)
|
69.78 minutes per milliliter (min/mL)
Standard Error 2.09
|
82.63 minutes per milliliter (min/mL)
Standard Error 2.15
|
83.49 minutes per milliliter (min/mL)
Standard Error 2.32
|
|
Least Square Means of Estimated GFR Calculated Using the Nankivell Equation by Visit
Month 30 (n=51,37,27)
|
68.41 minutes per milliliter (min/mL)
Standard Error 2.28
|
84.27 minutes per milliliter (min/mL)
Standard Error 2.46
|
82.02 minutes per milliliter (min/mL)
Standard Error 2.73
|
|
Least Square Means of Estimated GFR Calculated Using the Nankivell Equation by Visit
Month 36 (n=51,32,15)
|
68.94 minutes per milliliter (min/mL)
Standard Error 2.44
|
81.10 minutes per milliliter (min/mL)
Standard Error 2.66
|
81.50 minutes per milliliter (min/mL)
Standard Error 3.14
|
|
Least Square Means of Estimated GFR Calculated Using the Nankivell Equation by Visit
Month 42 (n=44,31,15)
|
68.82 minutes per milliliter (min/mL)
Standard Error 2.29
|
81.24 minutes per milliliter (min/mL)
Standard Error 2.49
|
77.81 minutes per milliliter (min/mL)
Standard Error 2.98
|
|
Least Square Means of Estimated GFR Calculated Using the Nankivell Equation by Visit
Month 48 (n=42,30,14)
|
67.68 minutes per milliliter (min/mL)
Standard Error 2.54
|
80.08 minutes per milliliter (min/mL)
Standard Error 2.79
|
75.28 minutes per milliliter (min/mL)
Standard Error 3.46
|
|
Least Square Means of Estimated GFR Calculated Using the Nankivell Equation by Visit
Month 54 (n=41,31,13)
|
65.59 minutes per milliliter (min/mL)
Standard Error 2.69
|
79.63 minutes per milliliter (min/mL)
Standard Error 2.98
|
75.82 minutes per milliliter (min/mL)
Standard Error 3.88
|
|
Least Square Means of Estimated GFR Calculated Using the Nankivell Equation by Visit
Month 66 (n=34,20,11)
|
68.99 minutes per milliliter (min/mL)
Standard Error 2.80
|
76.74 minutes per milliliter (min/mL)
Standard Error 3.17
|
75.01 minutes per milliliter (min/mL)
Standard Error 4.01
|
|
Least Square Means of Estimated GFR Calculated Using the Nankivell Equation by Visit
Month 72 (n=30,17,11)
|
68.65 minutes per milliliter (min/mL)
Standard Error 3.39
|
81.68 minutes per milliliter (min/mL)
Standard Error 4.01
|
72.92 minutes per milliliter (min/mL)
Standard Error 5.10
|
SECONDARY outcome
Timeframe: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72Population: Safety Analysis Set. n is the number of participants with the assessment at each visit.
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 (mL/min) was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight (kg)\*(140 minus age in years) divided by (72\*serum creatinine \[mg/dL\]). 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. Model contained treatment, visit and treatment by visit interaction as fixed effects. An unstructured variance-covariance structure was used.
Outcome measures
| Measure |
Cyclosporine
n=59 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=59 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=50 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Least Squares Means of Estimated GFR Calculated Using the Cockcroft-Gault Equation by Visit
Month 18
|
73.56 min/mL
Standard Error 3.14
|
87.52 min/mL
Standard Error 3.23
|
87.12 min/mL
Standard Error 3.42
|
|
Least Squares Means of Estimated GFR Calculated Using the Cockcroft-Gault Equation by Visit
Month 24 (n=58,54,42)
|
72.70 min/mL
Standard Error 3.28
|
87.72 min/mL
Standard Error 3.39
|
87.62 min/mL
Standard Error 3.62
|
|
Least Squares Means of Estimated GFR Calculated Using the Cockcroft-Gault Equation by Visit
Month 72 (n=30,17,11)
|
68.34 min/mL
Standard Error 4.44
|
85.50 min/mL
Standard Error 5.11
|
73.05 min/mL
Standard Error 6.45
|
|
Least Squares Means of Estimated GFR Calculated Using the Cockcroft-Gault Equation by Visit
Month 15
|
72.74 min/mL
Standard Error 3.02
|
87.22 min/mL
Standard Error 3.10
|
87.67 min/mL
Standard Error 3.29
|
|
Least Squares Means of Estimated GFR Calculated Using the Cockcroft-Gault Equation by Visit
Month 30 (n=51,38,29)
|
70.70 min/mL
Standard Error 3.48
|
89.24 min/mL
Standard Error 3.68
|
87.15 min/mL
Standard Error 3.99
|
|
Least Squares Means of Estimated GFR Calculated Using the Cockcroft-Gault Equation by Visit
Month 36 (n=51,32,15)
|
70.71 min/mL
Standard Error 3.75
|
85.91 min/mL
Standard Error 4.04
|
85.64 min/mL
Standard Error 4.68
|
|
Least Squares Means of Estimated GFR Calculated Using the Cockcroft-Gault Equation by Visit
Month 42 (n=44,31,15)
|
69.63 min/mL
Standard Error 3.48
|
85.95 min/mL
Standard Error 3.76
|
81.88 min/mL
Standard Error 4.45
|
|
Least Squares Means of Estimated GFR Calculated Using the Cockcroft-Gault Equation by Visit
Month 48 (n=42,30,14)
|
67.63 min/mL
Standard Error 3.81
|
83.96 min/mL
Standard Error 4.15
|
77.42 min/mL
Standard Error 5.03
|
|
Least Squares Means of Estimated GFR Calculated Using the Cockcroft-Gault Equation by Visit
Month 54 (n=41,31,13)
|
65.81 min/mL
Standard Error 3.85
|
82.78 min/mL
Standard Error 4.20
|
77.60 min/mL
Standard Error 5.26
|
|
Least Squares Means of Estimated GFR Calculated Using the Cockcroft-Gault Equation by Visit
Month 60 (n=37,24,12)
|
70.52 min/mL
Standard Error 3.92
|
78.54 min/mL
Standard Error 4.43
|
74.18 min/mL
Standard Error 5.63
|
|
Least Squares Means of Estimated GFR Calculated Using the Cockcroft-Gault Equation by Visit
Month 66 (n=34,20,11)
|
69.09 min/mL
Standard Error 3.81
|
79.09 min/mL
Standard Error 4.21
|
74.52 min/mL
Standard Error 5.11
|
SECONDARY outcome
Timeframe: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72Population: Safety Analysis Set.
GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR (mL/min/1.73 m\^2) by MDRD equation = 170 \* (serum creatinine \[mg/dL\])\^(-0.999) \* (age in years)\^(-0.176) \* (0.762 if female) \* (1.18 if black) \* (blood urea nitrogen concentration \[mg/dL\])\^(-0.170) \* (serum albumin concentration \[g/dL\])\^(0.318). 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. Model contained treatment, visit and treatment by visit interaction as fixed effects. An unstructured variance-covariance structure was used.
Outcome measures
| Measure |
Cyclosporine
n=64 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=60 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=54 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Least Squares Means of Estimated GFR (eGFR) (mL/Min/1.73 Square Meter [m^2]) Calculated by the Modification of Diet in Renal Disease (MDRD) Equation With Last Observation Carried Forward (LOCF) Plus Imputation (eGFR=0 for Graft Loss/Death) by Visit
Month 15
|
56.25 mL/min/1.73m^2
Standard Error 1.99
|
72.12 mL/min/1.73m^2
Standard Error 2.06
|
70.22 mL/min/1.73m^2
Standard Error 2.17
|
|
Least Squares Means of Estimated GFR (eGFR) (mL/Min/1.73 Square Meter [m^2]) Calculated by the Modification of Diet in Renal Disease (MDRD) Equation With Last Observation Carried Forward (LOCF) Plus Imputation (eGFR=0 for Graft Loss/Death) by Visit
Month 18
|
58.13 mL/min/1.73m^2
Standard Error 2.32
|
71.66 mL/min/1.73m^2
Standard Error 2.39
|
69.69 mL/min/1.73m^2
Standard Error 2.52
|
|
Least Squares Means of Estimated GFR (eGFR) (mL/Min/1.73 Square Meter [m^2]) Calculated by the Modification of Diet in Renal Disease (MDRD) Equation With Last Observation Carried Forward (LOCF) Plus Imputation (eGFR=0 for Graft Loss/Death) by Visit
Month 24
|
56.30 mL/min/1.73m^2
Standard Error 2.40
|
71.93 mL/min/1.73m^2
Standard Error 2.47
|
68.20 mL/min/1.73m^2
Standard Error 2.61
|
|
Least Squares Means of Estimated GFR (eGFR) (mL/Min/1.73 Square Meter [m^2]) Calculated by the Modification of Diet in Renal Disease (MDRD) Equation With Last Observation Carried Forward (LOCF) Plus Imputation (eGFR=0 for Graft Loss/Death) by Visit
Month 30
|
53.82 mL/min/1.73m^2
Standard Error 2.69
|
73.10 mL/min/1.73m^2
Standard Error 2.78
|
64.44 mL/min/1.73m^2
Standard Error 2.93
|
|
Least Squares Means of Estimated GFR (eGFR) (mL/Min/1.73 Square Meter [m^2]) Calculated by the Modification of Diet in Renal Disease (MDRD) Equation With Last Observation Carried Forward (LOCF) Plus Imputation (eGFR=0 for Graft Loss/Death) by Visit
Month 36
|
54.37 mL/min/1.73m^2
Standard Error 3.00
|
69.09 mL/min/1.73m^2
Standard Error 3.10
|
63.27 mL/min/1.73m^2
Standard Error 3.26
|
|
Least Squares Means of Estimated GFR (eGFR) (mL/Min/1.73 Square Meter [m^2]) Calculated by the Modification of Diet in Renal Disease (MDRD) Equation With Last Observation Carried Forward (LOCF) Plus Imputation (eGFR=0 for Graft Loss/Death) by Visit
Month 42
|
53.59 mL/min/1.73m^2
Standard Error 2.96
|
68.29 mL/min/1.73m^2
Standard Error 3.05
|
62.14 mL/min/1.73m^2
Standard Error 3.22
|
|
Least Squares Means of Estimated GFR (eGFR) (mL/Min/1.73 Square Meter [m^2]) Calculated by the Modification of Diet in Renal Disease (MDRD) Equation With Last Observation Carried Forward (LOCF) Plus Imputation (eGFR=0 for Graft Loss/Death) by Visit
Month 48
|
51.69 mL/min/1.73m^2
Standard Error 3.23
|
65.27 mL/min/1.73m^2
Standard Error 3.34
|
60.81 mL/min/1.73m^2
Standard Error 3.52
|
|
Least Squares Means of Estimated GFR (eGFR) (mL/Min/1.73 Square Meter [m^2]) Calculated by the Modification of Diet in Renal Disease (MDRD) Equation With Last Observation Carried Forward (LOCF) Plus Imputation (eGFR=0 for Graft Loss/Death) by Visit
Month 54
|
48.64 mL/min/1.73m^2
Standard Error 3.29
|
65.25 mL/min/1.73m^2
Standard Error 3.40
|
60.79 mL/min/1.73m^2
Standard Error 3.59
|
|
Least Squares Means of Estimated GFR (eGFR) (mL/Min/1.73 Square Meter [m^2]) Calculated by the Modification of Diet in Renal Disease (MDRD) Equation With Last Observation Carried Forward (LOCF) Plus Imputation (eGFR=0 for Graft Loss/Death) by Visit
Month 60
|
50.43 mL/min/1.73m^2
Standard Error 3.30
|
63.82 mL/min/1.73m^2
Standard Error 3.41
|
59.20 mL/min/1.73m^2
Standard Error 3.59
|
|
Least Squares Means of Estimated GFR (eGFR) (mL/Min/1.73 Square Meter [m^2]) Calculated by the Modification of Diet in Renal Disease (MDRD) Equation With Last Observation Carried Forward (LOCF) Plus Imputation (eGFR=0 for Graft Loss/Death) by Visit
Month 66
|
49.70 mL/min/1.73m^2
Standard Error 3.34
|
63.33 mL/min/1.73m^2
Standard Error 3.45
|
59.47 mL/min/1.73m^2
Standard Error 3.63
|
|
Least Squares Means of Estimated GFR (eGFR) (mL/Min/1.73 Square Meter [m^2]) Calculated by the Modification of Diet in Renal Disease (MDRD) Equation With Last Observation Carried Forward (LOCF) Plus Imputation (eGFR=0 for Graft Loss/Death) by Visit
Month 72
|
49.62 mL/min/1.73m^2
Standard Error 3.51
|
64.27 mL/min/1.73m^2
Standard Error 3.62
|
59.21 mL/min/1.73m^2
Standard Error 3.82
|
SECONDARY outcome
Timeframe: Months 24, 36Population: Safety Analysis Set. n is the number of participants with the assessment at each visit.
SF-36 v2 is a self-administered 36-item generic health status measure with 8 general health concepts which are the weighted sums of the questions in their section: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health. Each scale is transformed into a 0 (minimum) to 100 (maximum) scale on the assumption each question carries equal weight. These concepts were also summarized into 2 summary scores; Physical Component Summary and Mental Component Summary (both a 0-100 scale). The 8 subscales, 2 summary scores and transition Question 2 (TR Scale, measured on a scale of 1 \[minimum\] to 5 \[maximum\]) were subjected to analysis. Higher domain, summary scores, and TR scale scores indicate better health status. Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. First-order autoregressive variance-covariance structure was used.
Outcome measures
| Measure |
Cyclosporine
n=41 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=33 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=24 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 24: Physical Functioning
|
49.04 Score on a scale
Standard Error 1.16
|
47.00 Score on a scale
Standard Error 1.29
|
45.47 Score on a scale
Standard Error 1.49
|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 24: Role Physical
|
46.36 Score on a scale
Standard Error 1.41
|
47.72 Score on a scale
Standard Error 1.56
|
44.40 Score on a scale
Standard Error 1.82
|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 24: Bodily Pain
|
51.37 Score on a scale
Standard Error 1.42
|
51.66 Score on a scale
Standard Error 1.58
|
51.47 Score on a scale
Standard Error 1.84
|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 24: General Health
|
46.51 Score on a scale
Standard Error 1.19
|
48.25 Score on a scale
Standard Error 1.32
|
47.60 Score on a scale
Standard Error 1.54
|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 24: Vitality
|
53.31 Score on a scale
Standard Error 1.25
|
53.27 Score on a scale
Standard Error 1.39
|
55.07 Score on a scale
Standard Error 1.64
|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 24: Social Functioning
|
49.55 Score on a scale
Standard Error 1.33
|
49.41 Score on a scale
Standard Error 1.47
|
49.95 Score on a scale
Standard Error 1.74
|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 24: Role Emotional
|
44.65 Score on a scale
Standard Error 1.55
|
48.47 Score on a scale
Standard Error 1.72
|
44.17 Score on a scale
Standard Error 2.01
|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 24: Mental Health
|
49.52 Score on a scale
Standard Error 1.35
|
47.83 Score on a scale
Standard Error 1.50
|
53.08 Score on a scale
Standard Error 1.76
|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 24: TR Scale Score
|
2.63 Score on a scale
Standard Error 0.10
|
2.85 Score on a scale
Standard Error 0.12
|
2.86 Score on a scale
Standard Error 0.14
|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 24: Physical Component Summary
|
49.00 Score on a scale
Standard Error 1.13
|
48.99 Score on a scale
Standard Error 1.25
|
46.57 Score on a scale
Standard Error 1.45
|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 24: Mental Component Summary
|
48.65 Score on a scale
Standard Error 1.29
|
49.62 Score on a scale
Standard Error 1.43
|
51.92 Score on a scale
Standard Error 1.68
|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 36 (n=35,21,10): Physical Functioning
|
48.62 Score on a scale
Standard Error 1.25
|
46.97 Score on a scale
Standard Error 1.60
|
46.18 Score on a scale
Standard Error 2.27
|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 36 (n=35,21,10): Role Physical
|
48.00 Score on a scale
Standard Error 1.52
|
48.52 Score on a scale
Standard Error 1.94
|
46.00 Score on a scale
Standard Error 2.79
|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 36 (n=35,21,10): Bodily Pain
|
50.57 Score on a scale
Standard Error 1.54
|
52.66 Score on a scale
Standard Error 1.97
|
50.19 Score on a scale
Standard Error 2.84
|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 36 (n=35,21,10): General Health
|
46.06 Score on a scale
Standard Error 1.29
|
47.83 Score on a scale
Standard Error 1.63
|
47.02 Score on a scale
Standard Error 2.32
|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 36 (n=35,21,10): Vitality
|
53.01 Score on a scale
Standard Error 1.35
|
54.45 Score on a scale
Standard Error 1.73
|
57.43 Score on a scale
Standard Error 2.50
|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 36 (n=35,21,10): Social Functioning
|
48.96 Score on a scale
Standard Error 1.44
|
51.43 Score on a scale
Standard Error 1.84
|
48.33 Score on a scale
Standard Error 2.65
|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 36 (n=35,21,10): Role Emotional
|
46.35 Score on a scale
Standard Error 1.68
|
51.97 Score on a scale
Standard Error 2.15
|
47.58 Score on a scale
Standard Error 3.09
|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 36 (n=35,21,10): Mental health
|
50.21 Score on a scale
Standard Error 1.46
|
51.84 Score on a scale
Standard Error 1.86
|
50.59 Score on a scale
Standard Error 2.68
|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 36 (n=35,21,10): TR Scale Score
|
2.46 Score on a scale
Standard Error 0.11
|
2.65 Score on a scale
Standard Error 0.14
|
2.83 Score on a scale
Standard Error 0.21
|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 36 (n=35,21,10): Physical Component Summary
|
48.55 Score on a scale
Standard Error 1.22
|
48.00 Score on a scale
Standard Error 1.55
|
47.07 Score on a scale
Standard Error 2.21
|
|
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Month 36 (n=35,21,10): Mental Component Summary
|
49.45 Score on a scale
Standard Error 1.39
|
53.50 Score on a scale
Standard Error 1.77
|
52.32 Score on a scale
Standard Error 2.55
|
SECONDARY outcome
Timeframe: Months 24, 36Population: Safety Analysis Set. n is the number of participants with the assessment at each visit.
ESRD-SCL: a 43-item disease specific self-administered questionnaire. Participants' rated the question "At the moment,how much do you suffer?" for each item on a 5 point scale, range (Ra) from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: Cardiac and Renal (CR) dysfunction; Ra 0 to 28, Increased(In) Growth of Gum and Hair (IGGH); Ra 0 to 20, Limited Cognitive Capacity (LCC); Ra 0 to 32, Limited Physical Capacity (LPC); Ra 0 to 40, Side Effects (SEs) of Corticosteroids; Ra 0 to 20, Transplantation Associated Psychological Distress (TAPD); Ra 0 to 32. Total Score: 0 to 172, higher scores indicate greater dysfunction. Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.
Outcome measures
| Measure |
Cyclosporine
n=40 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=34 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=23 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36
Month 24 CR Dysfunction (n=40,33,23)
|
0.63 Score on a scale
Standard Error 0.07
|
0.58 Score on a scale
Standard Error 0.08
|
0.53 Score on a scale
Standard Error 0.10
|
|
Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36
Month 24 Limited Physical Capacity (n=40,33,23)
|
0.59 Score on a scale
Standard Error 0.07
|
0.70 Score on a scale
Standard Error 0.08
|
0.71 Score on a scale
Standard Error 0.10
|
|
Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36
Month 24 Limited Cognitive Capacity
|
0.63 Score on a scale
Standard Error 0.08
|
0.71 Score on a scale
Standard Error 0.08
|
0.75 Score on a scale
Standard Error 0.10
|
|
Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36
Month 24 SE of Corticosteroids (40, 33, 23)
|
0.42 Score on a scale
Standard Error 0.08
|
0.57 Score on a scale
Standard Error 0.09
|
0.60 Score on a scale
Standard Error 0.11
|
|
Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36
Month 24 IGGH (n=40,33,23)
|
0.54 Score on a scale
Standard Error 0.07
|
0.19 Score on a scale
Standard Error 0.08
|
0.17 Score on a scale
Standard Error 0.09
|
|
Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36
Month 24 TAPD
|
0.61 Score on a scale
Standard Error 0.08
|
0.77 Score on a scale
Standard Error 0.09
|
0.63 Score on a scale
Standard Error 0.11
|
|
Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36
Month 24 Global Score (n=40,33,23)
|
0.58 Score on a scale
Standard Error 0.06
|
0.62 Score on a scale
Standard Error 0.06
|
0.59 Score on a scale
Standard Error 0.07
|
|
Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36
Month 36 Limited Physical Capacity (n=33,21,8)
|
0.71 Score on a scale
Standard Error 0.08
|
0.69 Score on a scale
Standard Error 0.10
|
0.88 Score on a scale
Standard Error 0.16
|
|
Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36
Month 36 Limited Cognitive Capacity (n=34,21,8)
|
0.67 Score on a scale
Standard Error 0.08
|
0.73 Score on a scale
Standard Error 0.10
|
0.85 Score on a scale
Standard Error 0.17
|
|
Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36
Month 36 Cardiac and Renal Dysfunction (n=33,21,8)
|
0.58 Score on a scale
Standard Error 0.08
|
0.57 Score on a scale
Standard Error 0.10
|
0.76 Score on a scale
Standard Error 0.16
|
|
Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36
Month 36 SE of Corticosteroids (n=33,21,8)
|
0.44 Score on a scale
Standard Error 0.09
|
0.39 Score on a scale
Standard Error 0.11
|
0.58 Score on a scale
Standard Error 0.18
|
|
Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36
Month 36 IGGH (n=33,20,8)
|
0.54 Score on a scale
Standard Error 0.08
|
0.33 Score on a scale
Standard Error 0.10
|
0.23 Score on a scale
Standard Error 0.15
|
|
Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36
Month 36 TAPD (n=34,21,8)
|
0.77 Score on a scale
Standard Error 0.09
|
0.82 Score on a scale
Standard Error 0.11
|
0.68 Score on a scale
Standard Error 0.18
|
|
Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36
Month 36 Global Score (n=33,21,8)
|
0.64 Score on a scale
Standard Error 0.06
|
0.63 Score on a scale
Standard Error 0.08
|
0.70 Score on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Months 24, 36Population: Safety Analysis Set. n is the number of participants with the assessment at each visit.
SODA:17-item health scale, assessed participant-reported perceptions of dyspepsia; consists of 3 subscales: Pain Intensity (PI, 6-items to assess pain and intensity of abdominal discomfort; Range: 2 to 47, higher score indicates greater pain and abdominal discomfort), Non-Pain Symptoms (NPS, 7-items to assess severity and impact of non-pain symptoms: burping/belching, heartburn, bloating, flatulence, sour taste, nausea, and bad breath; Range: 7 to 35, higher scores indicate increased symptom severity and influence), and Satisfaction (4-items to assess degree of satisfaction with abdominal discomfort; Range: 2 to 23, higher scores indicate more satisfaction). Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.
Outcome measures
| Measure |
Cyclosporine
n=49 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=41 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=25 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Least Squares Means of Severity of Dyspepsia Assessment (SODA) Subscales at Months 24 & 36
Month 24 PI Total Converted Score (n=46,39,24)
|
9.51 Score
Standard Error 1.16
|
7.66 Score
Standard Error 1.26
|
10.73 Score
Standard Error 1.59
|
|
Least Squares Means of Severity of Dyspepsia Assessment (SODA) Subscales at Months 24 & 36
Month 24 NPS Converted Score
|
11.44 Score
Standard Error 0.42
|
11.24 Score
Standard Error 0.46
|
12.25 Score
Standard Error 0.58
|
|
Least Squares Means of Severity of Dyspepsia Assessment (SODA) Subscales at Months 24 & 36
Month 24 Satisfaction Converted Score (n=49,41,24)
|
17.22 Score
Standard Error 0.66
|
18.11 Score
Standard Error 0.72
|
16.33 Score
Standard Error 0.94
|
|
Least Squares Means of Severity of Dyspepsia Assessment (SODA) Subscales at Months 24 & 36
Month 36 PI Total Converted Score (n=40,27,10)
|
9.63 Score
Standard Error 1.25
|
8.03 Score
Standard Error 1.51
|
10.59 Score
Standard Error 2.45
|
|
Least Squares Means of Severity of Dyspepsia Assessment (SODA) Subscales at Months 24 & 36
Month 36 NPS Converted Score (n=42,28,10)
|
11.31 Score
Standard Error 0.45
|
11.14 Score
Standard Error 0.55
|
12.44 Score
Standard Error 0.91
|
|
Least Squares Means of Severity of Dyspepsia Assessment (SODA) Subscales at Months 24 & 36
Month 36 Satisfaction Converted Score (n=42,28,10)
|
17.44 Score
Standard Error 0.72
|
17.90 Score
Standard Error 0.87
|
16.31 Score
Standard Error 1.45
|
SECONDARY outcome
Timeframe: Months 18 and 24 (-2 hours, predose, 1 hour, 2 hours), Month 30 (predose, 1 hour and 2 hours), Month 36 (predose, 1, 2, and 4 hours), Months 42, 48, 54, 60, 66, 72 (predose and 2 hours)Population: Safety Analysis Set. n is the number of participants with the assessment at each time point.
The dates and times were recorded for the 6 doses of tofacitinib administered before each scheduled pharmacokinetic (PK) sampling. The participant was instructed to follow a 12 hourly schedule for these 6 doses of tofacitinib, with each dose administered within 1 hour of the scheduled time. Trough samples were collected 0 to 10 minutes prior to the morning dose. 1 hour postdose samples were required within 10 minutes of the nominal time point. Samples taken at -2 hours predose and at time points \>1 hour post dose were required within 30 minutes of the nominal time point.
Outcome measures
| Measure |
Cyclosporine
n=58 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=46 Participants
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Mean Trough Levels of Tofacitinib by Visit
Month 18 Predose -2 hours (n=31,22)
|
13.20 ng/mL
Standard Deviation 10.43
|
10.68 ng/mL
Standard Deviation 6.86
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 18 Predose
|
12.45 ng/mL
Standard Deviation 11.83
|
15.27 ng/mL
Standard Deviation 24.14
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 18 1 hour (n=58,45)
|
56.62 ng/mL
Standard Deviation 32.96
|
56.58 ng/mL
Standard Deviation 37.56
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 18 2 hours (n=26,23)
|
59.55 ng/mL
Standard Deviation 25.87
|
56.60 ng/mL
Standard Deviation 28.85
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 24 Predose -2 hours (n=18,15)
|
11.71 ng/mL
Standard Deviation 11.77
|
8.95 ng/mL
Standard Deviation 8.72
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 24 Predose (n=50,32)
|
9.93 ng/mL
Standard Deviation 14.50
|
7.42 ng/mL
Standard Deviation 4.88
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 24 1 hour (n=49,31)
|
44.06 ng/mL
Standard Deviation 26.16
|
41.93 ng/mL
Standard Deviation 27.27
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 24 2 hours (n=28,15)
|
37.73 ng/mL
Standard Deviation 14.00
|
34.15 ng/mL
Standard Deviation 15.27
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 30 Predose (n=35,21)
|
8.70 ng/mL
Standard Deviation 8.53
|
6.89 ng/mL
Standard Deviation 6.94
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 30 1 hour (n=35,21)
|
39.15 ng/mL
Standard Deviation 16.06
|
44.12 ng/mL
Standard Deviation 19.99
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 30 2 hours (n=34,19)
|
38.07 ng/mL
Standard Deviation 11.42
|
37.16 ng/mL
Standard Deviation 17.51
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 36 Predose (n=31,15)
|
6.35 ng/mL
Standard Deviation 4.68
|
8.33 ng/mL
Standard Deviation 10.76
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 36 1 hour (n=30,14)
|
46.09 ng/mL
Standard Deviation 12.54
|
38.07 ng/mL
Standard Deviation 14.06
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 36 2 hours (n=30,15)
|
38.11 ng/mL
Standard Deviation 14.41
|
31.76 ng/mL
Standard Deviation 7.45
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 36 4 hours (n=30,15)
|
24.03 ng/mL
Standard Deviation 10.34
|
21.46 ng/mL
Standard Deviation 4.33
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 42 Predose (n=31,14)
|
11.42 ng/mL
Standard Deviation 12.07
|
7.00 ng/mL
Standard Deviation 5.34
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 42 2 hours (n=30,12)
|
35.27 ng/mL
Standard Deviation 15.57
|
34.33 ng/mL
Standard Deviation 11.10
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 48 Predose (n=32,14)
|
7.58 ng/mL
Standard Deviation 6.94
|
13.78 ng/mL
Standard Deviation 11.05
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 48 2 hours (n=32,12)
|
38.46 ng/mL
Standard Deviation 12.36
|
41.10 ng/mL
Standard Deviation 12.35
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 54 Predose (n=30,11)
|
7.86 ng/mL
Standard Deviation 5.52
|
7.09 ng/mL
Standard Deviation 6.45
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 54 2 hours (n=30,10)
|
41.18 ng/mL
Standard Deviation 12.25
|
48.03 ng/mL
Standard Deviation 10.39
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 60 Predose (n=23,10)
|
6.58 ng/mL
Standard Deviation 3.82
|
7.31 ng/mL
Standard Deviation 5.41
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 60 2 hours (n=23,10)
|
39.43 ng/mL
Standard Deviation 9.26
|
38.98 ng/mL
Standard Deviation 13.33
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 66 Predose (n=22,10)
|
7.53 ng/mL
Standard Deviation 9.19
|
5.81 ng/mL
Standard Deviation 6.03
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 66 2 hours (n=21,10)
|
36.17 ng/mL
Standard Deviation 12.74
|
41.12 ng/mL
Standard Deviation 12.27
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 72 Predose (n=16,8)
|
8.30 ng/mL
Standard Deviation 7.22
|
5.37 ng/mL
Standard Deviation 5.05
|
—
|
|
Mean Trough Levels of Tofacitinib by Visit
Month 72 2 hours (n=16,8)
|
38.55 ng/mL
Standard Deviation 14.38
|
38.93 ng/mL
Standard Deviation 13.19
|
—
|
SECONDARY outcome
Timeframe: Predose: Months 18, 24, 36, 48, 60, 72Population: Safety Analysis Set. n is the number of participants with the assessment at each visit.
All CsA samples were taken predose (collected 0 to 10 minutes prior to the morning dose).
Outcome measures
| Measure |
Cyclosporine
n=58 Participants
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Mean Trough Levels of Cyclosporine by Visit
Month 18
|
113.88 ng/mL
Standard Deviation 98.73
|
—
|
—
|
|
Mean Trough Levels of Cyclosporine by Visit
Month 24 (n=54)
|
89.52 ng/mL
Standard Deviation 45.23
|
—
|
—
|
|
Mean Trough Levels of Cyclosporine by Visit
Month 36 (n=50)
|
101.10 ng/mL
Standard Deviation 100.63
|
—
|
—
|
|
Mean Trough Levels of Cyclosporine by Visit
Month 48 (n=39)
|
88.54 ng/mL
Standard Deviation 62.45
|
—
|
—
|
|
Mean Trough Levels of Cyclosporine by Visit
Month 60 (n=35)
|
95.00 ng/mL
Standard Deviation 115.74
|
—
|
—
|
|
Mean Trough Levels of Cyclosporine by Visit
Month 72 (n=23)
|
135.30 ng/mL
Standard Deviation 188.05
|
—
|
—
|
Adverse Events
Cyclosporine
Serious events: 40 serious events
Other events: 49 other events
Deaths: 0 deaths
Tofacitinib Less Intensive (LI)
Serious events: 32 serious events
Other events: 55 other events
Deaths: 0 deaths
Tofacitinib More Intensive (MI)
Serious events: 31 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cyclosporine
n=64 participants at risk
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=60 participants at risk
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=54 participants at risk
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Atrial flutter
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.7%
2/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Angina pectoris
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.7%
2/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Coronary artery dissection
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Coronary artery occlusion
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Coronary artery stenosis
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Myocardial infarction
|
3.1%
2/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Endocrine disorders
Hyperparathyrodism
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Endocrine disorders
Hyperparathyroidism tertiary
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Cataract
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Chronic gastritis
|
3.1%
2/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastric polyps
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
3.1%
2/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Intestinal dilatation
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Swollen tongue
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chest Pain
|
4.7%
3/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Drug ineffective
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Impaired healing
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Oedema
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
4.7%
3/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Immune system disorders
Kidney transplant rejection
|
3.1%
2/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.7%
2/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Immune system disorders
Transplant rejection
|
9.4%
6/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Abscess
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Arthritis bacterial
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Aspergilloma
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Atypical pneumonia
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Bacteraemia
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Cellulitis
|
3.1%
2/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Cytomegalovirus chorioretinitis
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Ear infection
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Gas gangrene
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
H1N1 influenza
|
3.1%
2/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Herpes zoster
|
3.1%
2/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Localised infection
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.7%
2/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Mycobacterium chelonae infection
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Orchitis
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Osteomyelitis
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Paronychia
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
6.2%
4/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.7%
2/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia bacterial
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Polyomavirus-associated nephropathy
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Postoperative wound infection
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pseudomonal sepsis
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pyelonephritis
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Sepsis
|
3.1%
2/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.6%
3/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Sinusitis
|
3.1%
2/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Wound infection
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Exposure during pregnancy
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Exposure via father
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Renal transplant failure
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Transplant dysfunction
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Urethral injury
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood creatinine increased
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.7%
2/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Liver function test abnormal
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Fluid retention
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.7%
2/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
3.1%
2/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Brain mass
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Epilepsy
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Somnolence
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Syncope
|
3.1%
2/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Unintended pregnancy
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Mental status changes
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Renal injury
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord cyst
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypertension
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypertensive crisis
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypovolaemic shock
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Superior vena cava occlusion
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Cyclosporine
n=64 participants at risk
CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib Less Intensive (LI)
n=60 participants at risk
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
Tofacitinib More Intensive (MI)
n=54 participants at risk
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
|
|---|---|---|---|
|
Vascular disorders
Hypertension
|
9.4%
6/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
7.4%
4/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
8/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.6%
3/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.2%
4/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
11.7%
7/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
4/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
4/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.7%
2/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.6%
10/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
15.0%
9/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
7.4%
4/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
9.4%
6/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
11.7%
7/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.7%
2/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
14.1%
9/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
13.3%
8/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.7%
2/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chest pain
|
10.9%
7/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
4.7%
3/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
8.3%
5/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.3%
5/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Oedema peripheral
|
6.2%
4/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
10/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
7.4%
4/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Peripheral swelling
|
4.7%
3/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
10.0%
6/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
4.7%
3/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
11.7%
7/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.6%
3/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Immune system disorders
Transplant rejection
|
7.8%
5/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
BK virus infection
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
10.0%
6/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Bronchitis
|
6.2%
4/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Epstein-Barr viraemia
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.6%
3/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.6%
3/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
3.1%
2/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
10.0%
6/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.7%
2/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Herpes zoster
|
4.7%
3/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
18.3%
11/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.3%
5/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
7.8%
5/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.6%
3/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Onychomycosis
|
3.1%
2/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
11.7%
7/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.7%
2/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.9%
7/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
10/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
24.1%
13/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
4/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.3%
5/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
4/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
11.1%
6/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
4.7%
3/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.3%
5/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood creatinine increased
|
10.9%
7/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.7%
2/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Cardiac murmur
|
3.1%
2/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
7.4%
4/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Weight decreased
|
3.1%
2/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
8.3%
5/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Weight increased
|
6.2%
4/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
8.3%
5/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.6%
3/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
3.1%
2/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.3%
5/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.6%
3/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.2%
4/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.7%
2/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Impaired fasting glucose
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.6%
3/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.6%
3/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.6%
10/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
13.3%
8/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
13.0%
7/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
8/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.7%
2/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.7%
3/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.6%
3/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
4/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
13.3%
8/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.7%
2/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
6.2%
4/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
11.7%
7/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
6.2%
4/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.7%
2/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
12.5%
8/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
11.7%
7/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.6%
3/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Tremor
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.6%
3/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Anxiety
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
8.3%
5/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
7.4%
4/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Depression
|
3.1%
2/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Insomnia
|
9.4%
6/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
8.3%
5/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Proteinuria
|
6.2%
4/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.6%
3/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/20 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Vulval disorder
|
0.00%
0/20 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.7%
3/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
11.1%
6/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.7%
3/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.6%
3/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.6%
3/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
3.1%
2/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.7%
2/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.6%
1/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
10.0%
6/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.7%
2/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
10.0%
2/20 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
8.3%
5/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
7.4%
4/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Social circumstances
Postmenopause
|
0.00%
0/20 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Haematoma
|
6.2%
4/64 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.9%
1/54 • Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60