Trial Outcomes & Findings for Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient (NCT NCT00263328)
NCT ID: NCT00263328
Last Updated: 2015-07-13
Results Overview
Kaplan-Meier analysis of percentage of participants with treatment failure by time to treatment failure within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Treatment failure was defined as the first occurrence of BPAR, death, graft loss or premature discontinuation of trial medication for any reason.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Results posted on
2015-07-13
Participant Flow
Participant milestones
| Measure |
Tacrolimus
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months posttransplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
14
|
13
|
|
Overall Study
COMPLETED
|
10
|
12
|
6
|
|
Overall Study
NOT COMPLETED
|
8
|
2
|
7
|
Reasons for withdrawal
| Measure |
Tacrolimus
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months posttransplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
1
|
|
Overall Study
Other
|
3
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
4
|
Baseline Characteristics
Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient
Baseline characteristics by cohort
| Measure |
Tofacitinib
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=13 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.6 Years
STANDARD_DEVIATION 9.3 • n=99 Participants
|
48.1 Years
STANDARD_DEVIATION 7.9 • n=107 Participants
|
44.5 Years
STANDARD_DEVIATION 12.2 • n=206 Participants
|
43.6 Years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR by MDRD equation = 170 \* (serum creatinine \[in milligrams per deciliter (mg/dL)\])\^(-0.999) \* (age in years)\^(-0.176) \* (0.762 if female) \* (1.18 if black) \* (blood urea nitrogen \[BUN\] concentration \[mg/dL\])\^(-0.170) \* (serum albumin concentration \[in grams per dL (g/dL)\])\^(0.318). A normal GFR is \>90 milliliters per minute per 1.73 square meters (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.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=12 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation
Month 9 (n=18,14,12)
|
67.06 mL/min/1.73 m^2
Standard Deviation 19.79
|
65.99 mL/min/1.73 m^2
Standard Deviation 12.46
|
67.05 mL/min/1.73 m^2
Standard Deviation 13.63
|
|
Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation
Month 15 (n=16,14,12)
|
66.22 mL/min/1.73 m^2
Standard Deviation 15.10
|
67.86 mL/min/1.73 m^2
Standard Deviation 9.33
|
65.71 mL/min/1.73 m^2
Standard Deviation 9.44
|
|
Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation
Month 12 (n=16,14,12)
|
64.97 mL/min/1.73 m^2
Standard Deviation 25.10
|
65.16 mL/min/1.73 m^2
Standard Deviation 11.90
|
63.50 mL/min/1.73 m^2
Standard Deviation 12.01
|
|
Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation
Month 18 (n=18,14,12)
|
72.81 mL/min/1.73 m^2
Standard Deviation 23.09
|
66.91 mL/min/1.73 m^2
Standard Deviation 12.19
|
64.71 mL/min/1.73 m^2
Standard Deviation 12.10
|
|
Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation
Month 24 (n=17,14,12)
|
77.05 mL/min/1.73 m^2
Standard Deviation 28.23
|
68.45 mL/min/1.73 m^2
Standard Deviation 10.47
|
66.29 mL/min/1.73 m^2
Standard Deviation 8.72
|
|
Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation
Month 30 (n=14,14,10)
|
79.89 mL/min/1.73 m^2
Standard Deviation 29.56
|
71.55 mL/min/1.73 m^2
Standard Deviation 7.33
|
64.04 mL/min/1.73 m^2
Standard Deviation 10.24
|
|
Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation
Month 36 (n=15,14,9)
|
79.87 mL/min/1.73 m^2
Standard Deviation 30.20
|
70.44 mL/min/1.73 m^2
Standard Deviation 13.65
|
61.72 mL/min/1.73 m^2
Standard Deviation 15.84
|
|
Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation
Month 42 (n=15,14,9)
|
77.95 mL/min/1.73 m^2
Standard Deviation 29.77
|
70.77 mL/min/1.73 m^2
Standard Deviation 16.05
|
65.25 mL/min/1.73 m^2
Standard Deviation 8.71
|
|
Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation
Month 48 (n=15,14,10)
|
76.23 mL/min/1.73 m^2
Standard Deviation 30.34
|
70.36 mL/min/1.73 m^2
Standard Deviation 14.36
|
65.50 mL/min/1.73 m^2
Standard Deviation 10.19
|
|
Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation
Month 54 (n=14,14,10)
|
78.10 mL/min/1.73 m^2
Standard Deviation 32.27
|
69.98 mL/min/1.73 m^2
Standard Deviation 15.18
|
61.99 mL/min/1.73 m^2
Standard Deviation 9.54
|
|
Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation
Month 60 (n=13,13,10)
|
82.86 mL/min/1.73 m^2
Standard Deviation 33.72
|
70.10 mL/min/1.73 m^2
Standard Deviation 18.01
|
67.30 mL/min/1.73 m^2
Standard Deviation 9.37
|
|
Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation
Month 66 (n=12,14,10)
|
89.80 mL/min/1.73 m^2
Standard Deviation 36.51
|
69.69 mL/min/1.73 m^2
Standard Deviation 18.23
|
64.98 mL/min/1.73 m^2
Standard Deviation 15.95
|
|
Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation
Month 72 (n=9,13,8)
|
76.61 mL/min/1.73 m^2
Standard Deviation 20.99
|
67.89 mL/min/1.73 m^2
Standard Deviation 11.61
|
61.96 mL/min/1.73 m^2
Standard Deviation 8.15
|
|
Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation
Month 78 (n=0,13,8)
|
NA mL/min/1.73 m^2
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
69.95 mL/min/1.73 m^2
Standard Deviation 14.40
|
68.64 mL/min/1.73 m^2
Standard Deviation 6.15
|
|
Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation
Month 84 (n=0,12,8)
|
NA mL/min/1.73 m^2
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
69.24 mL/min/1.73 m^2
Standard Deviation 13.80
|
68.77 mL/min/1.73 m^2
Standard Deviation 4.90
|
|
Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation
Month 90 (n=0,12,7)
|
NA mL/min/1.73 m^2
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
65.28 mL/min/1.73 m^2
Standard Deviation 14.19
|
69.46 mL/min/1.73 m^2
Standard Deviation 6.23
|
|
Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation
Month 96 (n=0,11,6)
|
NA mL/min/1.73 m^2
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
64.94 mL/min/1.73 m^2
Standard Deviation 14.01
|
70.33 mL/min/1.73 m^2
Standard Deviation 14.22
|
|
Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation
Follow-up (n=6,12,8)
|
42.29 mL/min/1.73 m^2
Standard Deviation 19.87
|
63.25 mL/min/1.73 m^2
Standard Deviation 14.07
|
60.41 mL/min/1.73 m^2
Standard Deviation 24.43
|
PRIMARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=12 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Serum Creatinine Levels
Month 78 (n=0,13,8)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
1.09 mg/dL
Standard Deviation 0.21
|
1.16 mg/dL
Standard Deviation 0.14
|
|
Serum Creatinine Levels
Month 60 (n=13,13,10)
|
1.17 mg/dL
Standard Deviation 0.40
|
1.12 mg/dL
Standard Deviation 0.35
|
1.16 mg/dL
Standard Deviation 0.13
|
|
Serum Creatinine Levels
Month 66 (n=12,14,10)
|
1.12 mg/dL
Standard Deviation 0.50
|
1.14 mg/dL
Standard Deviation 0.33
|
1.24 mg/dL
Standard Deviation 0.27
|
|
Serum Creatinine Levels
Month 72 (n=9,13,8)
|
1.12 mg/dL
Standard Deviation 0.26
|
1.09 mg/dL
Standard Deviation 0.21
|
1.29 mg/dL
Standard Deviation 0.21
|
|
Serum Creatinine Levels
Month 9 (n=18,14,12)
|
1.26 mg/dL
Standard Deviation 0.30
|
1.19 mg/dL
Standard Deviation 0.26
|
1.28 mg/dL
Standard Deviation 0.31
|
|
Serum Creatinine Levels
Month 12 (n=16,14,12)
|
1.34 mg/dL
Standard Deviation 0.30
|
1.21 mg/dL
Standard Deviation 0.30
|
1.33 mg/dL
Standard Deviation 0.32
|
|
Serum Creatinine Levels
Month 15 (n=16,14,12)
|
1.24 mg/dL
Standard Deviation 0.32
|
1.13 mg/dL
Standard Deviation 0.20
|
1.28 mg/dL
Standard Deviation 0.29
|
|
Serum Creatinine Levels
Month 18 (n=18,14,12)
|
1.18 mg/dL
Standard Deviation 0.30
|
1.15 mg/dL
Standard Deviation 0.23
|
1.29 mg/dL
Standard Deviation 0.29
|
|
Serum Creatinine Levels
Month 24 (n=17,14,12)
|
1.15 mg/dL
Standard Deviation 0.29
|
1.11 mg/dL
Standard Deviation 0.18
|
1.23 mg/dL
Standard Deviation 0.22
|
|
Serum Creatinine Levels
Month 30 (n=14,14,10)
|
1.14 mg/dL
Standard Deviation 0.36
|
1.06 mg/dL
Standard Deviation 0.16
|
1.24 mg/dL
Standard Deviation 0.22
|
|
Serum Creatinine Levels
Month 36 (n=15,14,9)
|
1.18 mg/dL
Standard Deviation 0.43
|
1.08 mg/dL
Standard Deviation 0.22
|
1.33 mg/dL
Standard Deviation 0.30
|
|
Serum Creatinine Levels
Month 42 (n=15,14,9)
|
1.19 mg/dL
Standard Deviation 0.42
|
1.09 mg/dL
Standard Deviation 0.27
|
1.17 mg/dL
Standard Deviation 0.12
|
|
Serum Creatinine Levels
Month 48 (n=15,14,10)
|
1.23 mg/dL
Standard Deviation 0.47
|
1.08 mg/dL
Standard Deviation 0.27
|
1.20 mg/dL
Standard Deviation 0.11
|
|
Serum Creatinine Levels
Month 54 (n=14,14,10)
|
1.38 mg/dL
Standard Deviation 1.04
|
1.10 mg/dL
Standard Deviation 0.26
|
1.25 mg/dL
Standard Deviation 0.14
|
|
Serum Creatinine Levels
Month 84 (n=0,12,8)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
1.10 mg/dL
Standard Deviation 0.21
|
1.15 mg/dL
Standard Deviation 0.15
|
|
Serum Creatinine Levels
Month 90 (n=0,12,7)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
1.16 mg/dL
Standard Deviation 0.25
|
1.16 mg/dL
Standard Deviation 0.19
|
|
Serum Creatinine Levels
Month 96 (n=0,11,6)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
1.15 mg/dL
Standard Deviation 0.25
|
1.10 mg/dL
Standard Deviation 0.14
|
|
Serum Creatinine Levels
Follow-Up (n=6,12,8)
|
2.35 mg/dL
Standard Deviation 2.11
|
1.16 mg/dL
Standard Deviation 0.27
|
1.50 mg/dL
Standard Deviation 0.84
|
PRIMARY outcome
Timeframe: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96Population: Safety population; n=number of participants remaining at risk for the specified parameter at a given visit.
Kaplan-Meier analysis of percentage of participants with clinically significant infections by time to first clinically significant infection within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.
Outcome measures
| Measure |
Tacrolimus
n=16 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=12 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit
Month 72 (n=4,8,2)
|
45.68 percentage of participants
|
42.86 percentage of participants
|
76.92 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit
Day 1 (n=18,14,13)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit
Month 1 (n=16,14,12)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit
Month 3 (n=16,13,7)
|
11.11 percentage of participants
|
7.14 percentage of participants
|
46.15 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit
Month 6 (n=14,12,4)
|
22.22 percentage of participants
|
14.29 percentage of participants
|
69.23 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit
Month 9 (n=13,11,4)
|
27.78 percentage of participants
|
21.43 percentage of participants
|
69.23 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit
Month 12 (n=12,9,4)
|
33.33 percentage of participants
|
35.71 percentage of participants
|
69.23 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit
Month 15 (n=11,8,3)
|
38.89 percentage of participants
|
42.86 percentage of participants
|
76.92 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit
Month 18 (n=10,8,3)
|
38.89 percentage of participants
|
42.86 percentage of participants
|
76.92 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit
Month 24 (n=10,8,3)
|
38.89 percentage of participants
|
42.86 percentage of participants
|
76.92 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit
Month 30 (n=9,8,3)
|
38.89 percentage of participants
|
42.86 percentage of participants
|
76.92 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit
Month 36 (n=8,8,3)
|
45.68 percentage of participants
|
42.86 percentage of participants
|
76.92 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit
Month 42 (n=8,8,2)
|
45.68 percentage of participants
|
42.86 percentage of participants
|
76.92 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit
Month 48 (n=7,8,2)
|
45.68 percentage of participants
|
42.86 percentage of participants
|
76.92 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit
Month 54 (n=7,8,2)
|
45.68 percentage of participants
|
42.86 percentage of participants
|
76.92 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit
Month 60 (n=7,8,2)
|
45.68 percentage of participants
|
42.86 percentage of participants
|
76.92 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit
Month 66 (n=7,8,2)
|
45.68 percentage of participants
|
42.86 percentage of participants
|
76.92 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit
Month 84 (n=0,8,2)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
42.86 percentage of participants
|
76.92 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit
Month 90 (n=0,8,2)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
42.86 percentage of participants
|
76.92 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit
Month 96 (n=0,8,2)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
42.86 percentage of participants
|
76.92 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96Population: Safety population; participants who had a history of diabetes at transplant were not included in the Kaplan-Meier analysis. n=number of participants remaining at risk for the specified parameter at a given visit.
Kaplan-Meier analysis of time to NODM-1 within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. NODM-1 was defined as an event experienced by participants who were non-diabetic prior to transplantation and required treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin for greater than or equal to (≥)30 days.
Outcome measures
| Measure |
Tacrolimus
n=17 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=8 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=9 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit
Month 12 (n=17,8,9)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit
Month 78 (n=0,8,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit
Month 66 (n=11,8,7)
|
6.25 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit
Month 3 (n=17,8,9)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit
Month 6 (n=17,8,9)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit
Month 9 (n=17,8,9)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit
Month 15 (n=17,8,9)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit
Month 18 (n=16,8,9)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit
Month 24 (n=15,8,9)
|
6.25 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit
Month 30 (n=13,8,8)
|
6.25 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit
Month 36 (n=13,8,8)
|
6.25 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit
Month 42 (n=13,8,8)
|
6.25 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit
Month 48 (n=12,8,8)
|
6.25 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit
Month 54 (n=12,8,8)
|
6.25 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit
Month 60 (n=11,8,8)
|
6.25 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit
Month 72 (n=6,8,7)
|
6.25 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit
Month 84 (n=0,8,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit
Month 1 (n=17,8,9)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit
Month 90 (n=0,8,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit
Month 96 (n=0,8,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0.00 percentage of participants
|
0.00 percentage of participants
|
PRIMARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96, and Follow-Up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Hypercholesterolemia was defined as cholesterol levels \>240 mg/dL or 6.2 mmol/L.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=13 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Percentage of Participants With Hypercholesterolemia
Month 9 (n=18,14,13)
|
11.1 percentage of participants
|
35.7 percentage of participants
|
15.4 percentage of participants
|
|
Percentage of Participants With Hypercholesterolemia
Month 12 (n=18,14,12)
|
5.6 percentage of participants
|
28.6 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants With Hypercholesterolemia
Month 15 (n=18,14,12)
|
5.6 percentage of participants
|
35.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Hypercholesterolemia
Month 18 (n=18,14,12)
|
5.6 percentage of participants
|
7.1 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants With Hypercholesterolemia
Month 24 (n=17,14,12)
|
11.8 percentage of participants
|
7.1 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With Hypercholesterolemia
Month 30 (n=15,14,11)
|
6.7 percentage of participants
|
7.1 percentage of participants
|
9.1 percentage of participants
|
|
Percentage of Participants With Hypercholesterolemia
Month 36 (n=15,14,11)
|
6.7 percentage of participants
|
0 percentage of participants
|
9.1 percentage of participants
|
|
Percentage of Participants With Hypercholesterolemia
Month 42 (n=15,14,10)
|
6.7 percentage of participants
|
21.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Hypercholesterolemia
Month 48 (n=15,14,10)
|
20.0 percentage of participants
|
7.1 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants With Hypercholesterolemia
Month 54 (n=14,14,10)
|
14.3 percentage of participants
|
21.4 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants With Hypercholesterolemia
Month 60 (n=13,14,10)
|
7.7 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Hypercholesterolemia
Month 66 (n=12,14,10)
|
16.7 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Hypercholesterolemia
Month 72 (n=9,13,8)
|
11.1 percentage of participants
|
15.4 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With Hypercholesterolemia
Month 78 (n=0,13,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
7.7 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With Hypercholesterolemia
Month 84 (n=0,13,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
7.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Hypercholesterolemia
Month 90 (n=0,12,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
8.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Hypercholesterolemia
Month 96 (n=0,11,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
9.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Hypercholesterolemia
Follow-Up (n=7,14,11)
|
14.3 percentage of participants
|
7.1 percentage of participants
|
9.1 percentage of participants
|
PRIMARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Hypertriglyceridemia was defined as triglyceride levels of \>200 mg/dL or 2.3 mmol/L.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=13 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Percentage of Participants With Hypertriglyceridemia by Visit
Month 78 (n=0,13,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
7.7 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With Hypertriglyceridemia by Visit
Month 96 (n=0,11,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
18.2 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Hypertriglyceridemia by Visit
Month 72 (n=9,13,8)
|
11.1 percentage of participants
|
23.1 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Hypertriglyceridemia by Visit
Month 9 (n=18,14,13)
|
11.1 percentage of participants
|
50.0 percentage of participants
|
38.5 percentage of participants
|
|
Percentage of Participants With Hypertriglyceridemia by Visit
Month 12 (n=18,14,12)
|
5.6 percentage of participants
|
42.9 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Hypertriglyceridemia by Visit
Month 15 (n=18,14,12)
|
5.6 percentage of participants
|
42.9 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants With Hypertriglyceridemia by Visit
Month 18 (n=18,14,12)
|
5.6 percentage of participants
|
35.7 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Hypertriglyceridemia by Visit
Month 24 (n=17,14,12)
|
17.6 percentage of participants
|
21.4 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Hypertriglyceridemia by Visit
Month 30 (n=15,14,11)
|
13.3 percentage of participants
|
28.6 percentage of participants
|
36.4 percentage of participants
|
|
Percentage of Participants With Hypertriglyceridemia by Visit
Month 36 (n=15,14,11)
|
20.0 percentage of participants
|
14.3 percentage of participants
|
27.3 percentage of participants
|
|
Percentage of Participants With Hypertriglyceridemia by Visit
Month 42 (n=15,14,10)
|
20.0 percentage of participants
|
35.7 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Hypertriglyceridemia by Visit
Month 48 (n=15,14,10)
|
20.0 percentage of participants
|
35.7 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants With Hypertriglyceridemia by Visit
Month 54 (n=14,14,10)
|
7.1 percentage of participants
|
35.7 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants With Hypertriglyceridemia by Visit
Month 60 (n=13,14,10)
|
15.4 percentage of participants
|
0 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants With Hypertriglyceridemia by Visit
Month 66 (n=12,14,10)
|
16.7 percentage of participants
|
14.3 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Hypertriglyceridemia by Visit
Month 84 (n=0,13,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
7.7 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With Hypertriglyceridemia by Visit
Month 90 (n=0,12,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
8.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Hypertriglyceridemia by Visit
Follow-Up (n=7,14,11)
|
14.3 percentage of participants
|
14.3 percentage of participants
|
27.3 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96Population: Safety population; n=number of participants remaining at risk for the specified parameter at a given visit.
Kaplan-Meier analysis of percentage of participants with first BPAR by time to first BPAR within 96 months post-transplant. BPAR was defined as acute/active cellular rejection (Category 4 of the Banff Classification), based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=13 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Day 1 (n=18,14,13)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 42 (n=14,14,9)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 84 (n=0,13,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 90 (n=0,13,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 15 (n=16,14,11)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 18 (n=16,14,11)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 24 (n=16,14,11)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 30 (n=14,14,10)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 36 (n=14,14,10)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 48 (n=13,14,9)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 54 (n=13,14,9)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 60 (n=12,14,9)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 66 (n=12,14,8)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 72 (n=5,14,7)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 78 (n=0,14,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 1 (n=17,14,13)
|
5.56 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 3 (n=17,14,11)
|
5.56 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 6 (n=17,14,11)
|
5.56 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 9 (n=16,14,11)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Month 12 (n=16,14,11)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96Population: Full Analysis Set (FAS): all participants who received at least 1 dose of study medication. n=number of participants remaining at risk for the specified parameter at a given visit.
Kaplan-Meier analysis of percentage of participants with treatment failure by time to treatment failure within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Treatment failure was defined as the first occurrence of BPAR, death, graft loss or premature discontinuation of trial medication for any reason.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=13 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Month 90 (n=0,12,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
14.29 percentage of participants
|
53.85 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Day 1 (n=18,14,13)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Month 1 (n=17,14,13)
|
5.56 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Month 3 (n=17,14,11)
|
5.56 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Month 6 (n=17,14,11)
|
5.56 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Month 9 (n=16,14,11)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Month 12 (n=16,14,10)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
23.08 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Month 15 (n=16,14,10)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
23.08 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Month 18 (n=16,14,10)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
23.08 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Month 24 (n=15,14,10)
|
16.67 percentage of participants
|
0.00 percentage of participants
|
23.08 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Month 30 (n=14,14,9)
|
22.22 percentage of participants
|
0.00 percentage of participants
|
30.77 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Month 36 (n=14,14,8)
|
22.22 percentage of participants
|
0.00 percentage of participants
|
38.46 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Month 42 (n=14,14,8)
|
22.22 percentage of participants
|
0.00 percentage of participants
|
38.46 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Month 48 (n=13,14,8)
|
27.78 percentage of participants
|
0.00 percentage of participants
|
38.46 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Month 54 (n=13,14,8)
|
27.78 percentage of participants
|
0.00 percentage of participants
|
38.46 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Month 60 (n=12,14,8)
|
33.33 percentage of participants
|
0.00 percentage of participants
|
38.46 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Month 66 (n=11,14,8)
|
38.89 percentage of participants
|
0.00 percentage of participants
|
38.46 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Month 72 (n=5,13,6)
|
50.00 percentage of participants
|
7.14 percentage of participants
|
53.85 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Month 78 (n=0,13,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
7.14 percentage of participants
|
53.85 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Month 84 (n=0,13,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
7.14 percentage of participants
|
53.85 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Month 96 (n=0,12,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
14.29 percentage of participants
|
53.85 percentage of participants
|
SECONDARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given 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 estimated by creatinine clearance (CLcr; in mL/min\]) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine \[in millimoles per liter (mmol/L)\]) plus (0.25\*body weight \[in kilograms (kg)\]) minus (0.5\*serum urea \[mmol/dL, where 1 mg/dL BUN=0.36 mmol/L urea\]) minus (100 per height \[in meters\] square) plus (35 for male/25 for female). A normal GFR is \>90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min indicated kidney failure.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=12 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Calculated GFR Using the Nankivell Equation (mL/Min)
Month 36 (n=15,14,9)
|
89.08 mL/min
Standard Deviation 24.53
|
86.05 mL/min
Standard Deviation 12.76
|
76.38 mL/min
Standard Deviation 15.14
|
|
Calculated GFR Using the Nankivell Equation (mL/Min)
Month 42 (n=15,14,9)
|
86.95 mL/min
Standard Deviation 17.96
|
86.07 mL/min
Standard Deviation 13.13
|
81.89 mL/min
Standard Deviation 7.03
|
|
Calculated GFR Using the Nankivell Equation (mL/Min)
Month 60 (n=13,13,10)
|
93.01 mL/min
Standard Deviation 19.88
|
85.75 mL/min
Standard Deviation 15.79
|
85.36 mL/min
Standard Deviation 10.01
|
|
Calculated GFR Using the Nankivell Equation (mL/Min)
Month 72 (n=9,13,8)
|
90.60 mL/min
Standard Deviation 17.58
|
83.80 mL/min
Standard Deviation 10.92
|
81.46 mL/min
Standard Deviation 7.94
|
|
Calculated GFR Using the Nankivell Equation (mL/Min)
Month 9 (n=18,14,12)
|
77.98 mL/min
Standard Deviation 11.29
|
80.15 mL/min
Standard Deviation 9.74
|
81.39 mL/min
Standard Deviation 9.77
|
|
Calculated GFR Using the Nankivell Equation (mL/Min)
Month 12 (n=16,14,12)
|
73.64 mL/min
Standard Deviation 15.23
|
80.02 mL/min
Standard Deviation 9.39
|
79.31 mL/min
Standard Deviation 11.71
|
|
Calculated GFR Using the Nankivell Equation (mL/Min)
Month 15 (n=16,14,12)
|
80.92 mL/min
Standard Deviation 12.79
|
83.06 mL/min
Standard Deviation 6.99
|
81.18 mL/min
Standard Deviation 10.61
|
|
Calculated GFR Using the Nankivell Equation (mL/Min)
Month 18 (n=18,14,12)
|
82.77 mL/min
Standard Deviation 14.14
|
81.72 mL/min
Standard Deviation 10.35
|
80.03 mL/min
Standard Deviation 10.82
|
|
Calculated GFR Using the Nankivell Equation (mL/Min)
Month 24 (n=17,14,12)
|
84.93 mL/min
Standard Deviation 14.36
|
82.62 mL/min
Standard Deviation 10.15
|
81.66 mL/min
Standard Deviation 8.20
|
|
Calculated GFR Using the Nankivell Equation (mL/Min)
Month 30 (n=14,14,10)
|
88.61 mL/min
Standard Deviation 16.59
|
86.35 mL/min
Standard Deviation 7.12
|
79.87 mL/min
Standard Deviation 9.74
|
|
Calculated GFR Using the Nankivell Equation (mL/Min)
Month 48 (n=15,14,10)
|
85.59 mL/min
Standard Deviation 21.32
|
86.47 mL/min
Standard Deviation 13.32
|
82.06 mL/min
Standard Deviation 8.68
|
|
Calculated GFR Using the Nankivell Equation (mL/Min)
Month 54 (n=14,14,10)
|
88.08 mL/min
Standard Deviation 27.63
|
85.35 mL/min
Standard Deviation 12.99
|
79.98 mL/min
Standard Deviation 10.36
|
|
Calculated GFR Using the Nankivell Equation (mL/Min)
Month 66 (n=12,14,10)
|
98.72 mL/min
Standard Deviation 33.70
|
84.26 mL/min
Standard Deviation 16.14
|
82.21 mL/min
Standard Deviation 17.48
|
|
Calculated GFR Using the Nankivell Equation (mL/Min)
Month 78 (n=0,13,8)
|
NA mL/min
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
83.94 mL/min
Standard Deviation 10.95
|
87.44 mL/min
Standard Deviation 8.72
|
|
Calculated GFR Using the Nankivell Equation (mL/Min)
Month 84 (n=0,12,8)
|
NA mL/min
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
84.21 mL/min
Standard Deviation 12.50
|
88.53 mL/min
Standard Deviation 5.40
|
|
Calculated GFR Using the Nankivell Equation (mL/Min)
Month 90 (n=0,12,7)
|
NA mL/min
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
81.09 mL/min
Standard Deviation 12.75
|
88.91 mL/min
Standard Deviation 6.31
|
|
Calculated GFR Using the Nankivell Equation (mL/Min)
Month 96 (n=0,11,6)
|
NA mL/min
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
79.46 mL/min
Standard Deviation 12.35
|
88.20 mL/min
Standard Deviation 8.93
|
|
Calculated GFR Using the Nankivell Equation (mL/Min)
Follow-Up (n=6,12,8)
|
52.35 mL/min
Standard Deviation 28.37
|
81.06 mL/min
Standard Deviation 12.76
|
76.41 mL/min
Standard Deviation 29.81
|
SECONDARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR 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.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=12 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Calculated GFR Using Cockcroft-Gault Equation (mL/Min)
Month 78 (n=0,13,8)
|
NA mL/min
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
85.10 mL/min
Standard Deviation 16.99
|
100.93 mL/min
Standard Deviation 20.40
|
|
Calculated GFR Using Cockcroft-Gault Equation (mL/Min)
Month 90 (n=0,12,7)
|
NA mL/min
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
80.73 mL/min
Standard Deviation 19.03
|
103.59 mL/min
Standard Deviation 16.99
|
|
Calculated GFR Using Cockcroft-Gault Equation (mL/Min)
Month 96 (n=0,11,6)
|
NA mL/min
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
79.02 mL/min
Standard Deviation 18.97
|
100.89 mL/min
Standard Deviation 14.55
|
|
Calculated GFR Using Cockcroft-Gault Equation (mL/Min)
Follow-Up (n=6,12,8)
|
63.95 mL/min
Standard Deviation 35.17
|
82.26 mL/min
Standard Deviation 17.32
|
89.79 mL/min
Standard Deviation 40.28
|
|
Calculated GFR Using Cockcroft-Gault Equation (mL/Min)
Month 9 (n=18,14,12)
|
92.82 mL/min
Standard Deviation 19.95
|
86.74 mL/min
Standard Deviation 15.70
|
92.35 mL/min
Standard Deviation 10.45
|
|
Calculated GFR Using Cockcroft-Gault Equation (mL/Min)
Month 12 (n=16,14,12)
|
87.05 mL/min
Standard Deviation 19.95
|
87.29 mL/min
Standard Deviation 17.83
|
90.36 mL/min
Standard Deviation 18.79
|
|
Calculated GFR Using Cockcroft-Gault Equation (mL/Min)
Month 15 (n=16,14,12)
|
98.39 mL/min
Standard Deviation 22.67
|
92.69 mL/min
Standard Deviation 15.97
|
92.79 mL/min
Standard Deviation 15.98
|
|
Calculated GFR Using Cockcroft-Gault Equation (mL/Min)
Month 18 (n=18,14,12)
|
98.68 mL/min
Standard Deviation 24.03
|
90.61 mL/min
Standard Deviation 16.53
|
91.31 mL/min
Standard Deviation 18.19
|
|
Calculated GFR Using Cockcroft-Gault Equation (mL/Min)
Month 24 (n=17,14,12)
|
100.46 mL/min
Standard Deviation 21.65
|
89.62 mL/min
Standard Deviation 24.06
|
94.67 mL/min
Standard Deviation 16.46
|
|
Calculated GFR Using Cockcroft-Gault Equation (mL/Min)
Month 30 (n=14,14,10)
|
102.29 mL/min
Standard Deviation 21.29
|
95.79 mL/min
Standard Deviation 20.38
|
88.19 mL/min
Standard Deviation 13.32
|
|
Calculated GFR Using Cockcroft-Gault Equation (mL/Min)
Month 36 (n=15,14,9)
|
101.92 mL/min
Standard Deviation 33.77
|
94.67 mL/min
Standard Deviation 23.12
|
86.32 mL/min
Standard Deviation 22.76
|
|
Calculated GFR Using Cockcroft-Gault Equation (mL/Min)
Month 42 (n=15,14,9)
|
102.79 mL/min
Standard Deviation 27.15
|
92.13 mL/min
Standard Deviation 19.39
|
91.96 mL/min
Standard Deviation 14.62
|
|
Calculated GFR Using Cockcroft-Gault Equation (mL/Min)
Month 48 (n=15,14,10)
|
100.77 mL/min
Standard Deviation 27.37
|
92.78 mL/min
Standard Deviation 23.60
|
93.23 mL/min
Standard Deviation 19.62
|
|
Calculated GFR Using Cockcroft-Gault Equation (mL/Min)
Month 54 (n=14,14,10)
|
106.65 mL/min
Standard Deviation 33.50
|
89.96 mL/min
Standard Deviation 19.19
|
91.90 mL/min
Standard Deviation 21.03
|
|
Calculated GFR Using Cockcroft-Gault Equation (mL/Min)
Month 60 (n=13,13,10)
|
113.73 mL/min
Standard Deviation 31.33
|
87.89 mL/min
Standard Deviation 21.20
|
98.94 mL/min
Standard Deviation 21.29
|
|
Calculated GFR Using Cockcroft-Gault Equation (mL/Min)
Month 66 (n=12,14,10)
|
118.60 mL/min
Standard Deviation 42.38
|
86.74 mL/min
Standard Deviation 20.14
|
94.80 mL/min
Standard Deviation 32.99
|
|
Calculated GFR Using Cockcroft-Gault Equation (mL/Min)
Month 72 (n=9,13,8)
|
113.23 mL/min
Standard Deviation 30.03
|
86.00 mL/min
Standard Deviation 17.77
|
93.33 mL/min
Standard Deviation 18.12
|
|
Calculated GFR Using Cockcroft-Gault Equation (mL/Min)
Month 84 (n=0,12,8)
|
NA mL/min
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
85.54 mL/min
Standard Deviation 19.31
|
102.36 mL/min
Standard Deviation 14.46
|
SECONDARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=12 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Reciprocal of Serum Creatinine
Month 90 (n=0,12,7)
|
NA dL/mg
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0.91 dL/mg
Standard Deviation 0.23
|
0.88 dL/mg
Standard Deviation 0.14
|
|
Reciprocal of Serum Creatinine
Month 96 (n=0,11,6)
|
NA dL/mg
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0.90 dL/mg
Standard Deviation 0.20
|
0.92 dL/mg
Standard Deviation 0.12
|
|
Reciprocal of Serum Creatinine
Follow-Up (n=6,12,8)
|
0.61 dL/mg
Standard Deviation 0.27
|
0.91 dL/mg
Standard Deviation 0.23
|
0.80 dL/mg
Standard Deviation 0.28
|
|
Reciprocal of Serum Creatinine
Month 9 (n=18,14,12)
|
0.83 dL/mg
Standard Deviation 0.17
|
0.88 dL/mg
Standard Deviation 0.22
|
0.83 dL/mg
Standard Deviation 0.20
|
|
Reciprocal of Serum Creatinine
Month 12 (n=16,14,12)
|
0.78 dL/mg
Standard Deviation 0.17
|
0.88 dL/mg
Standard Deviation 0.22
|
0.80 dL/mg
Standard Deviation 0.21
|
|
Reciprocal of Serum Creatinine
Month 15 (n=16,14,12)
|
0.85 dL/mg
Standard Deviation 0.19
|
0.91 dL/mg
Standard Deviation 0.17
|
0.82 dL/mg
Standard Deviation 0.20
|
|
Reciprocal of Serum Creatinine
Month 18 (n=18,14,12)
|
0.89 dL/mg
Standard Deviation 0.20
|
0.90 dL/mg
Standard Deviation 0.18
|
0.81 dL/mg
Standard Deviation 0.18
|
|
Reciprocal of Serum Creatinine
Month 24 (n=17,14,12)
|
0.92 dL/mg
Standard Deviation 0.22
|
0.93 dL/mg
Standard Deviation 0.16
|
0.83 dL/mg
Standard Deviation 0.15
|
|
Reciprocal of Serum Creatinine
Month 30 (n=14,14,10)
|
0.95 dL/mg
Standard Deviation 0.29
|
0.96 dL/mg
Standard Deviation 0.14
|
0.83 dL/mg
Standard Deviation 0.18
|
|
Reciprocal of Serum Creatinine
Month 36 (n=15,14,9)
|
0.96 dL/mg
Standard Deviation 0.38
|
0.96 dL/mg
Standard Deviation 0.20
|
0.78 dL/mg
Standard Deviation 0.14
|
|
Reciprocal of Serum Creatinine
Month 42 (n=15,14,9)
|
0.92 dL/mg
Standard Deviation 0.25
|
0.97 dL/mg
Standard Deviation 0.24
|
0.87 dL/mg
Standard Deviation 0.09
|
|
Reciprocal of Serum Creatinine
Month 48 (n=15,14,10)
|
0.91 dL/mg
Standard Deviation 0.27
|
0.98 dL/mg
Standard Deviation 0.23
|
0.84 dL/mg
Standard Deviation 0.08
|
|
Reciprocal of Serum Creatinine
Month 54 (n=14,14,10)
|
0.91 dL/mg
Standard Deviation 0.33
|
0.96 dL/mg
Standard Deviation 0.24
|
0.81 dL/mg
Standard Deviation 0.09
|
|
Reciprocal of Serum Creatinine
Month 60 (n=13,13,10)
|
0.94 dL/mg
Standard Deviation 0.29
|
0.97 dL/mg
Standard Deviation 0.26
|
0.87 dL/mg
Standard Deviation 0.10
|
|
Reciprocal of Serum Creatinine
Month 66 (n=12,14,10)
|
1.05 dL/mg
Standard Deviation 0.42
|
0.95 dL/mg
Standard Deviation 0.26
|
0.84 dL/mg
Standard Deviation 0.17
|
|
Reciprocal of Serum Creatinine
Month 72 (n=9,13,8)
|
0.94 dL/mg
Standard Deviation 0.24
|
0.95 dL/mg
Standard Deviation 0.20
|
0.79 dL/mg
Standard Deviation 0.12
|
|
Reciprocal of Serum Creatinine
Month 78 (n=0,13,8)
|
NA dL/mg
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0.95 dL/mg
Standard Deviation 0.21
|
0.87 dL/mg
Standard Deviation 0.10
|
|
Reciprocal of Serum Creatinine
Month 84 (n=0,12,8)
|
NA dL/mg
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0.94 dL/mg
Standard Deviation 0.20
|
0.88 dL/mg
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96Population: Safety population; n=number of participants remaining at risk for the specified parameter at a given visit. Participants who had a history of diabetes at transplant were not included in the Kaplan-Meier analysis.
Kaplan-Meier analysis of percentage of participants with NODM-2 by time to NODM-2 within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. NODM-2 was defined as an event experienced by a transplanted subject who meets any of the following criteria: (a) NODM-1; or (b) Symptoms of diabetes plus 2 casual serum glucose levels ≥200 mg/dL separated by at least approximately 24 hours. Casual was defined as any time of day without regard to time since last meal; or (c) Fasting serum glucose ≥126 mg/dL on 2 different occasions separated by at least approximately 24 hours. Fasting was defined as no caloric intake for at least 8 hours; or (d) 2-hour serum glucose ≥200 mg/dL during an OGTT (Oral Glucose Tolerance Test).
Outcome measures
| Measure |
Tacrolimus
n=17 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=8 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=9 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Month 9 (n=16,7,9)
|
5.88 percentage of participants
|
12.50 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Month 15 (n=16,7,9)
|
5.88 percentage of participants
|
12.50 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Month 36 (n=13,7,7)
|
5.88 percentage of participants
|
12.50 percentage of participants
|
12.50 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Month 42 (n=13,7,7)
|
5.88 percentage of participants
|
12.50 percentage of participants
|
12.50 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Month 54 (n=12,7,7)
|
5.88 percentage of participants
|
12.50 percentage of participants
|
12.50 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Month 72 (n=6,7,6)
|
14.44 percentage of participants
|
12.50 percentage of participants
|
12.50 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Day 1 (n=17,8,9)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Month 1 (n=17,8,9)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Month 3 (n=17,8,9)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Month 6 (n=17,8,9)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Month 12 (n=16,7,9)
|
5.88 percentage of participants
|
12.50 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Month 18 (n=15,7,9)
|
5.88 percentage of participants
|
12.50 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Month 24 (n=15,7,9)
|
5.88 percentage of participants
|
12.50 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Month 30 (n=13,7,7)
|
5.88 percentage of participants
|
12.50 percentage of participants
|
12.50 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Month 48 (n=12,7,7)
|
5.88 percentage of participants
|
12.50 percentage of participants
|
12.50 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Month 60 (n=11,7,7)
|
5.88 percentage of participants
|
12.50 percentage of participants
|
12.50 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Month 66 (n=11,7,6)
|
5.88 percentage of participants
|
12.50 percentage of participants
|
12.50 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Month 78 (n=0,7,5)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
12.50 percentage of participants
|
12.50 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Month 84 (n=0,7,5)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
12.50 percentage of participants
|
12.50 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Month 90 (n=0,7,5)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
12.50 percentage of participants
|
12.50 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Month 96 (n=0,7,5)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
12.50 percentage of participants
|
12.50 percentage of participants
|
SECONDARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=12 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Total Cholesterol Levels by Visit
Month 9 (n=18,14,12)
|
187.94 mg/dL
Standard Deviation 44.81
|
233.71 mg/dL
Standard Deviation 71.97
|
198.58 mg/dL
Standard Deviation 40.95
|
|
Total Cholesterol Levels by Visit
Month 12 (n=16,14,12)
|
180.31 mg/dL
Standard Deviation 46.99
|
228.57 mg/dL
Standard Deviation 64.34
|
210.08 mg/dL
Standard Deviation 44.32
|
|
Total Cholesterol Levels by Visit
Month 15 (n=16,14,12)
|
171.06 mg/dL
Standard Deviation 40.13
|
208.79 mg/dL
Standard Deviation 50.90
|
198.58 mg/dL
Standard Deviation 30.80
|
|
Total Cholesterol Levels by Visit
Month 18 (n=18,14,12)
|
173.28 mg/dL
Standard Deviation 41.76
|
185.21 mg/dL
Standard Deviation 45.99
|
192.00 mg/dL
Standard Deviation 42.14
|
|
Total Cholesterol Levels by Visit
Month 24 (n=17,14,12)
|
185.53 mg/dL
Standard Deviation 62.85
|
188.64 mg/dL
Standard Deviation 40.29
|
201.58 mg/dL
Standard Deviation 47.21
|
|
Total Cholesterol Levels by Visit
Month 30 (n=14,14,10)
|
175.43 mg/dL
Standard Deviation 44.91
|
185.71 mg/dL
Standard Deviation 37.82
|
198.30 mg/dL
Standard Deviation 36.42
|
|
Total Cholesterol Levels by Visit
Month 36 (n=15,14,9)
|
175.80 mg/dL
Standard Deviation 42.49
|
174.86 mg/dL
Standard Deviation 34.82
|
202.22 mg/dL
Standard Deviation 31.25
|
|
Total Cholesterol Levels by Visit
Month 42 (n=15,14,9)
|
179.87 mg/dL
Standard Deviation 40.82
|
206.29 mg/dL
Standard Deviation 78.76
|
187.67 mg/dL
Standard Deviation 22.57
|
|
Total Cholesterol Levels by Visit
Month 48 (n=15,14,10)
|
188.87 mg/dL
Standard Deviation 64.11
|
195.79 mg/dL
Standard Deviation 45.97
|
180.10 mg/dL
Standard Deviation 38.08
|
|
Total Cholesterol Levels by Visit
Month 54 (n=14,14,10)
|
184.86 mg/dL
Standard Deviation 43.06
|
201.79 mg/dL
Standard Deviation 51.39
|
183.70 mg/dL
Standard Deviation 42.50
|
|
Total Cholesterol Levels by Visit
Month 60 (n=13,13,10)
|
178.77 mg/dL
Standard Deviation 50.20
|
184.23 mg/dL
Standard Deviation 34.67
|
189.10 mg/dL
Standard Deviation 56.48
|
|
Total Cholesterol Levels by Visit
Month 66 (n=12,14,10)
|
188.25 mg/dL
Standard Deviation 46.65
|
185.64 mg/dL
Standard Deviation 46.46
|
172.20 mg/dL
Standard Deviation 36.33
|
|
Total Cholesterol Levels by Visit
Month 72 (n=9,12,8)
|
177.22 mg/dL
Standard Deviation 43.21
|
186.42 mg/dL
Standard Deviation 44.88
|
200.25 mg/dL
Standard Deviation 57.28
|
|
Total Cholesterol Levels by Visit
Month 78 (n=0,13,8)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
191.85 mg/dL
Standard Deviation 41.96
|
195.00 mg/dL
Standard Deviation 48.57
|
|
Total Cholesterol Levels by Visit
Month 84 (n=0,12,8)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
192.42 mg/dL
Standard Deviation 42.02
|
204.00 mg/dL
Standard Deviation 36.43
|
|
Total Cholesterol Levels by Visit
Month 90 (n=0,12,7)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
185.92 mg/dL
Standard Deviation 51.46
|
189.86 mg/dL
Standard Deviation 30.62
|
|
Total Cholesterol Levels by Visit
Month 96 (n=0,11,6)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
183.27 mg/dL
Standard Deviation 38.74
|
188.00 mg/dL
Standard Deviation 18.89
|
|
Total Cholesterol Levels by Visit
Follow-Up (n=6,12,8)
|
191.83 mg/dL
Standard Deviation 41.84
|
185.58 mg/dL
Standard Deviation 56.08
|
213.13 mg/dL
Standard Deviation 40.70
|
SECONDARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=12 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Low-Density Lipoprotein (LDL) Levels by Visit
Month 9 (n=18,12,11)
|
107.11 mg/dL
Standard Deviation 37.14
|
138.83 mg/dL
Standard Deviation 65.33
|
109.82 mg/dL
Standard Deviation 32.60
|
|
Low-Density Lipoprotein (LDL) Levels by Visit
Month 12 (n=16,14,12)
|
102.75 mg/dL
Standard Deviation 32.98
|
130.21 mg/dL
Standard Deviation 50.51
|
119.42 mg/dL
Standard Deviation 39.38
|
|
Low-Density Lipoprotein (LDL) Levels by Visit
Month 15 (n=16,14,11)
|
95.13 mg/dL
Standard Deviation 28.34
|
117.29 mg/dL
Standard Deviation 39.80
|
106.64 mg/dL
Standard Deviation 26.98
|
|
Low-Density Lipoprotein (LDL) Levels by Visit
Month 18 (n=18,14,12)
|
95.94 mg/dL
Standard Deviation 34.55
|
95.14 mg/dL
Standard Deviation 37.28
|
104.42 mg/dL
Standard Deviation 39.30
|
|
Low-Density Lipoprotein (LDL) Levels by Visit
Month 24 (n=17,14,12)
|
101.82 mg/dL
Standard Deviation 48.27
|
99.29 mg/dL
Standard Deviation 26.75
|
114.00 mg/dL
Standard Deviation 38.82
|
|
Low-Density Lipoprotein (LDL) Levels by Visit
Month 30 (n=14,14,10)
|
97.93 mg/dL
Standard Deviation 37.96
|
96.86 mg/dL
Standard Deviation 26.09
|
115.50 mg/dL
Standard Deviation 33.45
|
|
Low-Density Lipoprotein (LDL) Levels by Visit
Month 36 (n=15,14,9)
|
94.20 mg/dL
Standard Deviation 34.49
|
90.29 mg/dL
Standard Deviation 26.07
|
112.00 mg/dL
Standard Deviation 27.83
|
|
Low-Density Lipoprotein (LDL) Levels by Visit
Month 42 (n=15,13,9)
|
100.27 mg/dL
Standard Deviation 34.56
|
99.69 mg/dL
Standard Deviation 36.08
|
102.11 mg/dL
Standard Deviation 24.94
|
|
Low-Density Lipoprotein (LDL) Levels by Visit
Month 48 (n=15,14,10)
|
110.13 mg/dL
Standard Deviation 55.46
|
107.07 mg/dL
Standard Deviation 29.03
|
99.70 mg/dL
Standard Deviation 34.56
|
|
Low-Density Lipoprotein (LDL) Levels by Visit
Month 54 (n=14,13,10)
|
108.36 mg/dL
Standard Deviation 40.27
|
109.08 mg/dL
Standard Deviation 32.78
|
96.50 mg/dL
Standard Deviation 41.04
|
|
Low-Density Lipoprotein (LDL) Levels by Visit
Month 60 (n=13,13,10)
|
105.62 mg/dL
Standard Deviation 42.86
|
101.00 mg/dL
Standard Deviation 24.15
|
98.60 mg/dL
Standard Deviation 44.67
|
|
Low-Density Lipoprotein (LDL) Levels by Visit
Month 66 (n=12,13,10)
|
109.83 mg/dL
Standard Deviation 44.59
|
100.92 mg/dL
Standard Deviation 33.67
|
91.90 mg/dL
Standard Deviation 33.14
|
|
Low-Density Lipoprotein (LDL) Levels by Visit
Month 72 (n=9,12,8)
|
102.89 mg/dL
Standard Deviation 43.96
|
100.00 mg/dL
Standard Deviation 28.63
|
114.25 mg/dL
Standard Deviation 46.57
|
|
Low-Density Lipoprotein (LDL) Levels by Visit
Month 78 (n=0,12,8)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
103.25 mg/dL
Standard Deviation 31.13
|
111.13 mg/dL
Standard Deviation 41.46
|
|
Low-Density Lipoprotein (LDL) Levels by Visit
Month 84 (n=0,12,8)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
103.92 mg/dL
Standard Deviation 37.55
|
117.88 mg/dL
Standard Deviation 32.73
|
|
Low-Density Lipoprotein (LDL) Levels by Visit
Month 90 (n=0,12,7)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
101.92 mg/dL
Standard Deviation 41.67
|
99.00 mg/dL
Standard Deviation 23.93
|
|
Low-Density Lipoprotein (LDL) Levels by Visit
Month 96 (n=0,11,6)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
93.82 mg/dL
Standard Deviation 28.22
|
99.83 mg/dL
Standard Deviation 30.30
|
|
Low-Density Lipoprotein (LDL) Levels by Visit
Follow-Up (n=6,12,8)
|
110.00 mg/dL
Standard Deviation 49.37
|
102.42 mg/dL
Standard Deviation 46.08
|
129.38 mg/dL
Standard Deviation 39.71
|
SECONDARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=12 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
High-Density Lipoprotein (HDL) Levels by Visit
Month 18 (n=18,14,12)
|
52.67 mg/dL
Standard Deviation 17.07
|
59.29 mg/dL
Standard Deviation 17.03
|
52.92 mg/dL
Standard Deviation 15.17
|
|
High-Density Lipoprotein (HDL) Levels by Visit
Month 24 (n=17,14,12)
|
53.76 mg/dL
Standard Deviation 18.60
|
60.07 mg/dL
Standard Deviation 17.09
|
55.17 mg/dL
Standard Deviation 17.78
|
|
High-Density Lipoprotein (HDL) Levels by Visit
Month 30 (n=14,14,10)
|
51.21 mg/dL
Standard Deviation 16.83
|
59.29 mg/dL
Standard Deviation 15.03
|
50.40 mg/dL
Standard Deviation 9.29
|
|
High-Density Lipoprotein (HDL) Levels by Visit
Month 36 (n=15,14,9)
|
53.13 mg/dL
Standard Deviation 16.92
|
55.14 mg/dL
Standard Deviation 15.42
|
56.44 mg/dL
Standard Deviation 13.51
|
|
High-Density Lipoprotein (HDL) Levels by Visit
Follow-Up (n=6,12,8)
|
55.67 mg/dL
Standard Deviation 10.95
|
56.25 mg/dL
Standard Deviation 15.78
|
45.38 mg/dL
Standard Deviation 12.64
|
|
High-Density Lipoprotein (HDL) Levels by Visit
Month 9 (n=18,14,12)
|
54.83 mg/dL
Standard Deviation 14.92
|
59.93 mg/dL
Standard Deviation 14.38
|
52.58 mg/dL
Standard Deviation 16.32
|
|
High-Density Lipoprotein (HDL) Levels by Visit
Month 12 (n=16,14,12)
|
51.81 mg/dL
Standard Deviation 18.82
|
62.07 mg/dL
Standard Deviation 17.68
|
56.00 mg/dL
Standard Deviation 16.99
|
|
High-Density Lipoprotein (HDL) Levels by Visit
Month 15 (n=16,14,12)
|
51.31 mg/dL
Standard Deviation 16.08
|
59.79 mg/dL
Standard Deviation 16.37
|
53.08 mg/dL
Standard Deviation 16.72
|
|
High-Density Lipoprotein (HDL) Levels by Visit
Month 42 (n=15,14,9)
|
52.27 mg/dL
Standard Deviation 14.40
|
56.57 mg/dL
Standard Deviation 12.69
|
57.33 mg/dL
Standard Deviation 12.23
|
|
High-Density Lipoprotein (HDL) Levels by Visit
Month 48 (n=15,14,10)
|
49.67 mg/dL
Standard Deviation 16.56
|
57.71 mg/dL
Standard Deviation 17.73
|
50.10 mg/dL
Standard Deviation 10.63
|
|
High-Density Lipoprotein (HDL) Levels by Visit
Month 54 (n=14,14,10)
|
46.64 mg/dL
Standard Deviation 13.28
|
60.07 mg/dL
Standard Deviation 16.36
|
52.80 mg/dL
Standard Deviation 12.27
|
|
High-Density Lipoprotein (HDL) Levels by Visit
Month 60 (n=13,13,10)
|
45.23 mg/dL
Standard Deviation 11.89
|
58.23 mg/dL
Standard Deviation 15.69
|
58.30 mg/dL
Standard Deviation 28.33
|
|
High-Density Lipoprotein (HDL) Levels by Visit
Month 66 (n=12,14,10)
|
49.75 mg/dL
Standard Deviation 15.72
|
56.57 mg/dL
Standard Deviation 19.03
|
51.40 mg/dL
Standard Deviation 13.92
|
|
High-Density Lipoprotein (HDL) Levels by Visit
Month 72 (n=9,12,8)
|
46.67 mg/dL
Standard Deviation 12.40
|
62.67 mg/dL
Standard Deviation 15.25
|
48.38 mg/dL
Standard Deviation 14.06
|
|
High-Density Lipoprotein (HDL) Levels by Visit
Month 78 (n=0,12,8)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
65.58 mg/dL
Standard Deviation 18.75
|
49.38 mg/dL
Standard Deviation 14.79
|
|
High-Density Lipoprotein (HDL) Levels by Visit
Month 84 (n=0,12,8)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
63.00 mg/dL
Standard Deviation 17.79
|
46.38 mg/dL
Standard Deviation 10.16
|
|
High-Density Lipoprotein (HDL) Levels by Visit
Month 90 (n=0,12,7)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
61.17 mg/dL
Standard Deviation 14.94
|
49.57 mg/dL
Standard Deviation 9.43
|
|
High-Density Lipoprotein (HDL) Levels by Visit
Month 96 (n=0,11,6)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
65.36 mg/dL
Standard Deviation 18.78
|
52.00 mg/dL
Standard Deviation 10.97
|
SECONDARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=12 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Ratio of Total Serum Cholesterol Level to HDL Level by Visit
Month 9 (n=18,14,12)
|
3.62 ratio
Standard Deviation 1.05
|
4.09 ratio
Standard Deviation 1.47
|
4.08 ratio
Standard Deviation 1.34
|
|
Ratio of Total Serum Cholesterol Level to HDL Level by Visit
Month 12 (n=16,14,12)
|
3.72 ratio
Standard Deviation 0.94
|
3.92 ratio
Standard Deviation 1.40
|
4.03 ratio
Standard Deviation 1.34
|
|
Ratio of Total Serum Cholesterol Level to HDL Level by Visit
Month 15 (n=16,14,12)
|
3.48 ratio
Standard Deviation 0.78
|
3.66 ratio
Standard Deviation 1.04
|
4.08 ratio
Standard Deviation 1.33
|
|
Ratio of Total Serum Cholesterol Level to HDL Level by Visit
Month 18 (n=18,14,12)
|
3.50 ratio
Standard Deviation 1.01
|
3.32 ratio
Standard Deviation 1.03
|
3.88 ratio
Standard Deviation 1.29
|
|
Ratio of Total Serum Cholesterol Level to HDL Level by Visit
Month 24 (n=17,14,12)
|
3.69 ratio
Standard Deviation 1.28
|
3.35 ratio
Standard Deviation 1.06
|
3.97 ratio
Standard Deviation 1.43
|
|
Ratio of Total Serum Cholesterol Level to HDL Level by Visit
Month 30 (n=14,14,10)
|
3.70 ratio
Standard Deviation 1.30
|
3.30 ratio
Standard Deviation 0.99
|
4.03 ratio
Standard Deviation 0.89
|
|
Ratio of Total Serum Cholesterol Level to HDL Level by Visit
Month 36 (n=15,14,9)
|
3.54 ratio
Standard Deviation 1.23
|
3.35 ratio
Standard Deviation 0.89
|
3.68 ratio
Standard Deviation 0.61
|
|
Ratio of Total Serum Cholesterol Level to HDL Level by Visit
Month 42 (n=15,14,9)
|
3.63 ratio
Standard Deviation 1.00
|
3.85 ratio
Standard Deviation 1.82
|
3.35 ratio
Standard Deviation 0.50
|
|
Ratio of Total Serum Cholesterol Level to HDL Level by Visit
Month 48 (n=15,14,10)
|
3.95 ratio
Standard Deviation 1.04
|
3.59 ratio
Standard Deviation 1.09
|
3.76 ratio
Standard Deviation 1.20
|
|
Ratio of Total Serum Cholesterol Level to HDL Level by Visit
Month 54 (n=14,14,10)
|
4.17 ratio
Standard Deviation 1.22
|
3.52 ratio
Standard Deviation 1.14
|
3.64 ratio
Standard Deviation 1.23
|
|
Ratio of Total Serum Cholesterol Level to HDL Level by Visit
Month 60 (n=13,13,10)
|
4.12 ratio
Standard Deviation 1.18
|
3.32 ratio
Standard Deviation 0.87
|
3.59 ratio
Standard Deviation 1.20
|
|
Ratio of Total Serum Cholesterol Level to HDL Level by Visit
Month 66 (n=12,14,10)
|
3.99 ratio
Standard Deviation 1.00
|
3.51 ratio
Standard Deviation 1.08
|
3.50 ratio
Standard Deviation 0.93
|
|
Ratio of Total Serum Cholesterol Level to HDL Level by Visit
Month 72 (n=9,12,8)
|
3.97 ratio
Standard Deviation 1.08
|
3.05 ratio
Standard Deviation 0.62
|
4.30 ratio
Standard Deviation 1.31
|
|
Ratio of Total Serum Cholesterol Level to HDL Level by Visit
Month 78 (n=0,12,8)
|
NA ratio
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
3.06 ratio
Standard Deviation 0.96
|
4.06 ratio
Standard Deviation 0.89
|
|
Ratio of Total Serum Cholesterol Level to HDL Level by Visit
Month 84 (n=0,12,8)
|
NA ratio
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
3.22 ratio
Standard Deviation 0.99
|
4.50 ratio
Standard Deviation 0.96
|
|
Ratio of Total Serum Cholesterol Level to HDL Level by Visit
Month 90 (n=0,12,7)
|
NA ratio
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
3.14 ratio
Standard Deviation 0.89
|
3.91 ratio
Standard Deviation 0.74
|
|
Ratio of Total Serum Cholesterol Level to HDL Level by Visit
Month 96 (n=0,11,6)
|
NA ratio
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
2.97 ratio
Standard Deviation 0.92
|
3.72 ratio
Standard Deviation 0.69
|
|
Ratio of Total Serum Cholesterol Level to HDL Level by Visit
Follow-Up (n=6,12,8)
|
3.57 ratio
Standard Deviation 1.06
|
3.45 ratio
Standard Deviation 1.07
|
4.95 ratio
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=12 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit
Month 9 (n=18,14,12)
|
94.4 percentage of participants
|
71.4 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit
Month 12 (n=16,14,12)
|
87.5 percentage of participants
|
85.7 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit
Month 18 (n=18,14,12)
|
88.9 percentage of participants
|
92.9 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit
Month 24 (n=17,14,12)
|
88.2 percentage of participants
|
85.7 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit
Month 66 (n=12,14,10)
|
83.3 percentage of participants
|
92.9 percentage of participants
|
90.0 percentage of participants
|
|
Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit
Month 15 (n=16,14,12)
|
93.8 percentage of participants
|
92.9 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit
Month 30 (n=14,14,10)
|
78.6 percentage of participants
|
92.9 percentage of participants
|
70.0 percentage of participants
|
|
Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit
Month 36 (n=15,14,9)
|
86.7 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit
Month 42 (n=15,14,9)
|
86.7 percentage of participants
|
78.6 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit
Month 48 (n=15,14,10)
|
86.7 percentage of participants
|
92.9 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit
Month 54 (n=14,14,10)
|
78.6 percentage of participants
|
85.7 percentage of participants
|
90.0 percentage of participants
|
|
Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit
Month 60 (n=13,13,10)
|
69.2 percentage of participants
|
92.3 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit
Month 72 (n=9,12,8)
|
88.9 percentage of participants
|
100.0 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit
Month 78 (n=0,12,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
100.0 percentage of participants
|
87.5 percentage of participants
|
|
Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit
Month 84 (n=0,12,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
91.7 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit
Month 90 (n=0,12,7)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit
Month 96 (n=0,11,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit
Follow-Up (n=6,12,8)
|
100.0 percentage of participants
|
91.7 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=12 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Ratio of Serum LDL Level to HDL Level by Visit
Month 54 (n=14,13,10)
|
2.48 ratio
Standard Deviation 1.08
|
1.92 ratio
Standard Deviation 0.81
|
1.92 ratio
Standard Deviation 1.02
|
|
Ratio of Serum LDL Level to HDL Level by Visit
Month 9 (n=18,12,11)
|
2.09 ratio
Standard Deviation 0.84
|
2.42 ratio
Standard Deviation 1.25
|
2.17 ratio
Standard Deviation 0.82
|
|
Ratio of Serum LDL Level to HDL Level by Visit
Month 12 (n=16,14,12)
|
2.14 ratio
Standard Deviation 0.71
|
2.24 ratio
Standard Deviation 0.98
|
2.31 ratio
Standard Deviation 0.99
|
|
Ratio of Serum LDL Level to HDL Level by Visit
Month 15 (n=16,14,11)
|
1.97 ratio
Standard Deviation 0.62
|
2.07 ratio
Standard Deviation 0.81
|
2.11 ratio
Standard Deviation 0.74
|
|
Ratio of Serum LDL Level to HDL Level by Visit
Month 18 (n=18,14,12)
|
1.98 ratio
Standard Deviation 0.86
|
1.74 ratio
Standard Deviation 0.80
|
2.10 ratio
Standard Deviation 0.93
|
|
Ratio of Serum LDL Level to HDL Level by Visit
Month 24 (n=17,14,12)
|
2.04 ratio
Standard Deviation 0.94
|
1.78 ratio
Standard Deviation 0.69
|
2.25 ratio
Standard Deviation 0.98
|
|
Ratio of Serum LDL Level to HDL Level by Visit
Month 30 (n=14,14,10)
|
2.09 ratio
Standard Deviation 0.99
|
1.76 ratio
Standard Deviation 0.69
|
2.36 ratio
Standard Deviation 0.78
|
|
Ratio of Serum LDL Level to HDL Level by Visit
Month 36 (n=15,14,9)
|
1.93 ratio
Standard Deviation 0.92
|
1.75 ratio
Standard Deviation 0.64
|
2.03 ratio
Standard Deviation 0.49
|
|
Ratio of Serum LDL Level to HDL Level by Visit
Month 42 (n=15,13,9)
|
2.06 ratio
Standard Deviation 0.87
|
1.85 ratio
Standard Deviation 0.81
|
1.82 ratio
Standard Deviation 0.44
|
|
Ratio of Serum LDL Level to HDL Level by Visit
Month 48 (n=15,14,10)
|
2.27 ratio
Standard Deviation 0.85
|
1.99 ratio
Standard Deviation 0.73
|
2.07 ratio
Standard Deviation 0.80
|
|
Ratio of Serum LDL Level to HDL Level by Visit
Month 60 (n=13,13,10)
|
2.45 ratio
Standard Deviation 0.99
|
1.86 ratio
Standard Deviation 0.67
|
1.92 ratio
Standard Deviation 0.98
|
|
Ratio of Serum LDL Level to HDL Level by Visit
Month 66 (n=12,13,10)
|
2.34 ratio
Standard Deviation 0.91
|
1.96 ratio
Standard Deviation 0.85
|
1.88 ratio
Standard Deviation 0.83
|
|
Ratio of Serum LDL Level to HDL Level by Visit
Month 72 (n=9,12,8)
|
2.32 ratio
Standard Deviation 1.00
|
1.66 ratio
Standard Deviation 0.50
|
2.46 ratio
Standard Deviation 1.04
|
|
Ratio of Serum LDL Level to HDL Level by Visit
Month 78 (n=0,12,8)
|
NA ratio
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
1.72 ratio
Standard Deviation 0.77
|
2.30 ratio
Standard Deviation 0.80
|
|
Ratio of Serum LDL Level to HDL Level by Visit
Month 84 (n=0,12,8)
|
NA ratio
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
1.80 ratio
Standard Deviation 0.83
|
2.58 ratio
Standard Deviation 0.69
|
|
Ratio of Serum LDL Level to HDL Level by Visit
Month 90 (n=0,12,7)
|
NA ratio
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
1.74 ratio
Standard Deviation 0.74
|
2.04 ratio
Standard Deviation 0.50
|
|
Ratio of Serum LDL Level to HDL Level by Visit
Month 96 (n=0,11,6)
|
NA ratio
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
1.56 ratio
Standard Deviation 0.66
|
1.98 ratio
Standard Deviation 0.69
|
|
Ratio of Serum LDL Level to HDL Level by Visit
Follow-up (n=6,12,8)
|
2.09 ratio
Standard Deviation 1.05
|
1.91 ratio
Standard Deviation 0.82
|
3.03 ratio
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=12 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit
Month 9 (n=18,12,11)
|
94.4 percentage of participants
|
75.0 percentage of participants
|
90.9 percentage of participants
|
|
Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit
Month 12 (n=16,14,12)
|
93.8 percentage of participants
|
85.7 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit
Month 15 (n=16,14,11)
|
100.0 percentage of participants
|
92.9 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit
Month 18 (n=18,14,12)
|
94.4 percentage of participants
|
100.0 percentage of participants
|
91.7 percentage of participants
|
|
Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit
Month 24 (n=17,14,12)
|
94.1 percentage of participants
|
100.0 percentage of participants
|
91.7 percentage of participants
|
|
Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit
Month 30 (n=14,14,10)
|
78.6 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit
Month 36 (n=15,14,9)
|
93.3 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit
Month 42 (n=15,13,9)
|
93.3 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit
Month 48 (n=15,14,10)
|
93.3 percentage of participants
|
92.9 percentage of participants
|
90.0 percentage of participants
|
|
Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit
Month 54 (n=14,13,10)
|
71.4 percentage of participants
|
92.3 percentage of participants
|
90.0 percentage of participants
|
|
Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit
Month 60 (n=13,13,10)
|
76.9 percentage of participants
|
100.0 percentage of participants
|
90.0 percentage of participants
|
|
Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit
Month 66 (n=12,13,10)
|
83.3 percentage of participants
|
92.3 percentage of participants
|
90.0 percentage of participants
|
|
Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit
Month 72 (n=9,12,8)
|
88.9 percentage of participants
|
100.0 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit
Month 78 (n=0,12,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
100.0 percentage of participants
|
87.5 percentage of participants
|
|
Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit
Month 84 (n=0,12,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
100.0 percentage of participants
|
87.5 percentage of participants
|
|
Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit
Month 90 (n=0,12,7)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit
Month 96 (n=0,11,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit
Follow-Up (n=6,12,8)
|
100.0 percentage of participants
|
91.7 percentage of participants
|
62.5 percentage of participants
|
SECONDARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=12 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Serum Triglyceride Levels by Visit
Month 9 (n=18,14,12)
|
129.44 mg/dL
Standard Deviation 53.45
|
205.07 mg/dL
Standard Deviation 139.91
|
194.00 mg/dL
Standard Deviation 128.60
|
|
Serum Triglyceride Levels by Visit
Month 12 (n=16,14,12)
|
129.19 mg/dL
Standard Deviation 49.86
|
181.86 mg/dL
Standard Deviation 107.49
|
173.00 mg/dL
Standard Deviation 99.25
|
|
Serum Triglyceride Levels by Visit
Month 15 (n=16,14,12)
|
123.56 mg/dL
Standard Deviation 52.90
|
158.93 mg/dL
Standard Deviation 84.58
|
200.50 mg/dL
Standard Deviation 122.75
|
|
Serum Triglyceride Levels by Visit
Month 18 (n=18,14,12)
|
123.44 mg/dL
Standard Deviation 53.83
|
153.79 mg/dL
Standard Deviation 79.29
|
173.08 mg/dL
Standard Deviation 101.81
|
|
Serum Triglyceride Levels by Visit
Month 24 (n=17,14,12)
|
149.71 mg/dL
Standard Deviation 86.56
|
146.50 mg/dL
Standard Deviation 106.28
|
161.33 mg/dL
Standard Deviation 83.95
|
|
Serum Triglyceride Levels by Visit
Month 30 (n=14,14,10)
|
131.07 mg/dL
Standard Deviation 52.76
|
147.71 mg/dL
Standard Deviation 84.28
|
162.30 mg/dL
Standard Deviation 55.08
|
|
Serum Triglyceride Levels by Visit
Month 36 (n=15,14,9)
|
142.00 mg/dL
Standard Deviation 68.44
|
147.14 mg/dL
Standard Deviation 93.13
|
169.11 mg/dL
Standard Deviation 79.39
|
|
Serum Triglyceride Levels by Visit
Month 42 (n=15,14,9)
|
136.60 mg/dL
Standard Deviation 52.91
|
195.71 mg/dL
Standard Deviation 156.42
|
141.22 mg/dL
Standard Deviation 63.76
|
|
Serum Triglyceride Levels by Visit
Month 48 (n=15,14,10)
|
144.67 mg/dL
Standard Deviation 70.99
|
155.07 mg/dL
Standard Deviation 91.61
|
150.70 mg/dL
Standard Deviation 106.82
|
|
Serum Triglyceride Levels by Visit
Month 54 (n=14,14,10)
|
150.14 mg/dL
Standard Deviation 47.64
|
158.43 mg/dL
Standard Deviation 115.94
|
170.90 mg/dL
Standard Deviation 83.72
|
|
Serum Triglyceride Levels by Visit
Month 60 (n=13,13,10)
|
139.38 mg/dL
Standard Deviation 71.94
|
125.23 mg/dL
Standard Deviation 46.55
|
161.10 mg/dL
Standard Deviation 93.01
|
|
Serum Triglyceride Levels by Visit
Month 66 (n=12,14,10)
|
143.42 mg/dL
Standard Deviation 54.70
|
140.00 mg/dL
Standard Deviation 117.56
|
145.30 mg/dL
Standard Deviation 75.77
|
|
Serum Triglyceride Levels by Visit
Month 72 (n=9,12,8)
|
138.33 mg/dL
Standard Deviation 59.14
|
118.33 mg/dL
Standard Deviation 83.47
|
188.00 mg/dL
Standard Deviation 72.59
|
|
Serum Triglyceride Levels by Visit
Month 78 (n=0,12,8)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
104.42 mg/dL
Standard Deviation 58.22
|
172.38 mg/dL
Standard Deviation 53.73
|
|
Serum Triglyceride Levels by Visit
Month 84 (n=0,12,8)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
127.17 mg/dL
Standard Deviation 66.01
|
199.75 mg/dL
Standard Deviation 84.79
|
|
Serum Triglyceride Levels by Visit
Month 90 (n=0,12,7)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
113.75 mg/dL
Standard Deviation 57.79
|
206.29 mg/dL
Standard Deviation 83.17
|
|
Serum Triglyceride Levels by Visit
Month 96 (n=0,11,6)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
119.64 mg/dL
Standard Deviation 76.86
|
180.17 mg/dL
Standard Deviation 93.92
|
|
Serum Triglyceride Levels by Visit
Follow-Up (n=6,12,8)
|
130.67 mg/dL
Standard Deviation 63.87
|
134.50 mg/dL
Standard Deviation 73.14
|
191.88 mg/dL
Standard Deviation 83.21
|
SECONDARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=13 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Percentage of Participants Requiring Lipid-Lowering Agents by Visit
Month 9 (n=18,14,13)
|
38.9 percentage of participants
|
64.3 percentage of participants
|
53.8 percentage of participants
|
|
Percentage of Participants Requiring Lipid-Lowering Agents by Visit
Month 12 (n=18,14,13)
|
44.4 percentage of participants
|
64.3 percentage of participants
|
53.8 percentage of participants
|
|
Percentage of Participants Requiring Lipid-Lowering Agents by Visit
Month 15 (n=18,14,12)
|
44.4 percentage of participants
|
71.4 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Requiring Lipid-Lowering Agents by Visit
Month 18 (n=18,14,12)
|
44.4 percentage of participants
|
71.4 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants Requiring Lipid-Lowering Agents by Visit
Month 24 (n=17,14,12)
|
47.1 percentage of participants
|
71.4 percentage of participants
|
58.3 percentage of participants
|
|
Percentage of Participants Requiring Lipid-Lowering Agents by Visit
Month 30 (n=15,14,11)
|
46.7 percentage of participants
|
71.4 percentage of participants
|
63.6 percentage of participants
|
|
Percentage of Participants Requiring Lipid-Lowering Agents by Visit
Month 36 (n=15,14,11)
|
46.7 percentage of participants
|
71.4 percentage of participants
|
72.7 percentage of participants
|
|
Percentage of Participants Requiring Lipid-Lowering Agents by Visit
Month 42 (n=15,14,10)
|
46.7 percentage of participants
|
64.3 percentage of participants
|
90.0 percentage of participants
|
|
Percentage of Participants Requiring Lipid-Lowering Agents by Visit
Month 48 (n=15,14,10)
|
46.7 percentage of participants
|
64.3 percentage of participants
|
90.0 percentage of participants
|
|
Percentage of Participants Requiring Lipid-Lowering Agents by Visit
Month 54 (n=14,14,10)
|
42.9 percentage of participants
|
64.3 percentage of participants
|
70.0 percentage of participants
|
|
Percentage of Participants Requiring Lipid-Lowering Agents by Visit
Month 60 (n=13,14,10)
|
38.5 percentage of participants
|
64.3 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants Requiring Lipid-Lowering Agents by Visit
Month 66 (n=13,14,10)
|
46.2 percentage of participants
|
64.3 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants Requiring Lipid-Lowering Agents by Visit
Month 72 (n=9,14,9)
|
44.4 percentage of participants
|
64.3 percentage of participants
|
88.9 percentage of participants
|
|
Percentage of Participants Requiring Lipid-Lowering Agents by Visit
Month 78 (n=0,13,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
61.5 percentage of participants
|
87.5 percentage of participants
|
|
Percentage of Participants Requiring Lipid-Lowering Agents by Visit
Month 84 (n=0,13,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
61.5 percentage of participants
|
87.5 percentage of participants
|
|
Percentage of Participants Requiring Lipid-Lowering Agents by Visit
Month 90 (n=0,12,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
58.3 percentage of participants
|
87.5 percentage of participants
|
|
Percentage of Participants Requiring Lipid-Lowering Agents by Visit
Month 96 (n=0,12,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
58.3 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=13 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Percentage of Participants Requiring Anti-Hypertensive Medication by Visit
Month 90 (n=0,12,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
66.7 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants Requiring Anti-Hypertensive Medication by Visit
Month 96 (n=0,11,7)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
72.7 percentage of participants
|
71.4 percentage of participants
|
|
Percentage of Participants Requiring Anti-Hypertensive Medication by Visit
Month 9 (n=18,14,13)
|
83.3 percentage of participants
|
85.7 percentage of participants
|
92.3 percentage of participants
|
|
Percentage of Participants Requiring Anti-Hypertensive Medication by Visit
Month 12 (n=18,14,13)
|
83.3 percentage of participants
|
85.7 percentage of participants
|
92.3 percentage of participants
|
|
Percentage of Participants Requiring Anti-Hypertensive Medication by Visit
Month 15 (n=18,14,12)
|
83.3 percentage of participants
|
85.7 percentage of participants
|
91.7 percentage of participants
|
|
Percentage of Participants Requiring Anti-Hypertensive Medication by Visit
Month 18 (n=18,14,12)
|
83.3 percentage of participants
|
78.6 percentage of participants
|
91.7 percentage of participants
|
|
Percentage of Participants Requiring Anti-Hypertensive Medication by Visit
Month 24 (n=17,14,12)
|
82.4 percentage of participants
|
85.7 percentage of participants
|
91.7 percentage of participants
|
|
Percentage of Participants Requiring Anti-Hypertensive Medication by Visit
Month 30 (n=15,14,11)
|
73.3 percentage of participants
|
71.4 percentage of participants
|
81.8 percentage of participants
|
|
Percentage of Participants Requiring Anti-Hypertensive Medication by Visit
Month 36 (n=15,14,10)
|
73.3 percentage of participants
|
71.4 percentage of participants
|
90.0 percentage of participants
|
|
Percentage of Participants Requiring Anti-Hypertensive Medication by Visit
Month 42 (n=15,14,10)
|
73.3 percentage of participants
|
71.4 percentage of participants
|
90.0 percentage of participants
|
|
Percentage of Participants Requiring Anti-Hypertensive Medication by Visit
Month 48 (n=15,14,10)
|
73.3 percentage of participants
|
71.4 percentage of participants
|
90.0 percentage of participants
|
|
Percentage of Participants Requiring Anti-Hypertensive Medication by Visit
Month 54 (n=14,14,10)
|
71.4 percentage of participants
|
71.4 percentage of participants
|
90.0 percentage of participants
|
|
Percentage of Participants Requiring Anti-Hypertensive Medication by Visit
Month 60 (n=13,14,10)
|
69.2 percentage of participants
|
71.4 percentage of participants
|
90.0 percentage of participants
|
|
Percentage of Participants Requiring Anti-Hypertensive Medication by Visit
Month 66 (n=13,14,10)
|
76.9 percentage of participants
|
71.4 percentage of participants
|
90.0 percentage of participants
|
|
Percentage of Participants Requiring Anti-Hypertensive Medication by Visit
Month 72 (n=9,14,9)
|
77.8 percentage of participants
|
71.4 percentage of participants
|
88.9 percentage of participants
|
|
Percentage of Participants Requiring Anti-Hypertensive Medication by Visit
Month 78 (n=0,13,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
69.2 percentage of participants
|
87.5 percentage of participants
|
|
Percentage of Participants Requiring Anti-Hypertensive Medication by Visit
Month 84 (n=0,13,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
69.2 percentage of participants
|
75.0 percentage of participants
|
SECONDARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=13 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit
Month 9 (n=18,14,13)
|
5.6 percentage of participants
|
35.7 percentage of participants
|
30.8 percentage of participants
|
|
Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit
Month 12 (n=18,14,12)
|
5.6 percentage of participants
|
35.7 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit
Month 36 (n=15,14,10)
|
13.3 percentage of participants
|
42.9 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit
Month 42 (n=15,14,10)
|
13.3 percentage of participants
|
42.9 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit
Month 48 (n=15,14,10)
|
13.3 percentage of participants
|
42.9 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit
Month 15 (n=18,14,12)
|
5.6 percentage of participants
|
42.9 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit
Month 18 (n=18,14,12)
|
11.1 percentage of participants
|
42.9 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit
Month 24 (n=17,14,12)
|
11.8 percentage of participants
|
42.9 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit
Month 30 (n=15,14,11)
|
13.3 percentage of participants
|
42.9 percentage of participants
|
27.3 percentage of participants
|
|
Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit
Month 54 (n=14,14,10)
|
14.3 percentage of participants
|
42.9 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit
Month 60 (n=13,14,10)
|
15.4 percentage of participants
|
42.9 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit
Month 66 (n=13,14,10)
|
15.4 percentage of participants
|
42.9 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit
Month 72 (n=9,14,8)
|
11.1 percentage of participants
|
42.9 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit
Month 78 (n=0,13,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
38.5 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit
Month 84 (n=0,13,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
38.5 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit
Month 90 (n=0,12,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
33.3 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit
Month 96 (n=0,11,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
36.4 percentage of participants
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Calculated as number of copies per 500 mg DNA.
Outcome measures
| Measure |
Tacrolimus
n=17 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=12 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit
Month 9 (n=17,14,12)
|
0.41 number of copies/500 mg DNA
Standard Deviation 1.46
|
1.00 number of copies/500 mg DNA
Standard Deviation 2.18
|
3.17 number of copies/500 mg DNA
Standard Deviation 3.30
|
|
Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit
Month 12 (n=17,14,12)
|
0.12 number of copies/500 mg DNA
Standard Deviation 0.49
|
4.07 number of copies/500 mg DNA
Standard Deviation 11.89
|
8.42 number of copies/500 mg DNA
Standard Deviation 18.46
|
|
Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit
Month 15 (n=17,14,12)
|
5.47 number of copies/500 mg DNA
Standard Deviation 22.05
|
6.71 number of copies/500 mg DNA
Standard Deviation 20.36
|
18.42 number of copies/500 mg DNA
Standard Deviation 24.27
|
|
Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit
Month 18 (n=17,13,12)
|
0.59 number of copies/500 mg DNA
Standard Deviation 2.18
|
21.92 number of copies/500 mg DNA
Standard Deviation 56.56
|
21.50 number of copies/500 mg DNA
Standard Deviation 32.52
|
|
Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit
Month 24 (n=15,13,12)
|
0.00 number of copies/500 mg DNA
Standard Deviation 0.00
|
10.38 number of copies/500 mg DNA
Standard Deviation 24.22
|
10.83 number of copies/500 mg DNA
Standard Deviation 25.90
|
|
Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit
Month 30 (n=13,14,10)
|
2.15 number of copies/500 mg DNA
Standard Deviation 7.19
|
13.57 number of copies/500 mg DNA
Standard Deviation 31.74
|
23.80 number of copies/500 mg DNA
Standard Deviation 39.60
|
|
Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit
Month 36 (n=15,14,8)
|
1.20 number of copies/500 mg DNA
Standard Deviation 3.19
|
8.64 number of copies/500 mg DNA
Standard Deviation 25.37
|
42.63 number of copies/500 mg DNA
Standard Deviation 110.49
|
|
Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit
Month 42 (n=14,12,9)
|
0.57 number of copies/500 mg DNA
Standard Deviation 2.14
|
15.50 number of copies/500 mg DNA
Standard Deviation 19.10
|
17.00 number of copies/500 mg DNA
Standard Deviation 26.98
|
|
Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit
Month 48 (n=15,9,6)
|
0.07 number of copies/500 mg DNA
Standard Deviation 0.26
|
17.00 number of copies/500 mg DNA
Standard Deviation 32.60
|
11.50 number of copies/500 mg DNA
Standard Deviation 21.42
|
|
Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit
Month 54 (n=14,14,10)
|
0.64 number of copies/500 mg DNA
Standard Deviation 1.08
|
13.86 number of copies/500 mg DNA
Standard Deviation 26.40
|
6.30 number of copies/500 mg DNA
Standard Deviation 12.10
|
|
Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit
Month 60 (n=13,13,10)
|
0.31 number of copies/500 mg DNA
Standard Deviation 0.63
|
11.46 number of copies/500 mg DNA
Standard Deviation 27.20
|
10.20 number of copies/500 mg DNA
Standard Deviation 20.86
|
|
Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit
Month 66 (n=10,13,9)
|
0.40 number of copies/500 mg DNA
Standard Deviation 0.97
|
17.38 number of copies/500 mg DNA
Standard Deviation 26.83
|
31.11 number of copies/500 mg DNA
Standard Deviation 32.92
|
|
Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit
Month 72 (n=9,12,8)
|
1.11 number of copies/500 mg DNA
Standard Deviation 3.33
|
11.08 number of copies/500 mg DNA
Standard Deviation 27.22
|
19.25 number of copies/500 mg DNA
Standard Deviation 41.80
|
|
Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit
Month 78 (n=0,12,8)
|
NA number of copies/500 mg DNA
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
10.08 number of copies/500 mg DNA
Standard Deviation 16.10
|
17.63 number of copies/500 mg DNA
Standard Deviation 42.28
|
|
Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit
Month 84 (n=0,12,8)
|
NA number of copies/500 mg DNA
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
1.08 number of copies/500 mg DNA
Standard Deviation 1.51
|
10.88 number of copies/500 mg DNA
Standard Deviation 21.24
|
|
Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit
Month 90 (n=0,12,7)
|
NA number of copies/500 mg DNA
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
2.92 number of copies/500 mg DNA
Standard Deviation 5.18
|
9.29 number of copies/500 mg DNA
Standard Deviation 20.69
|
|
Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit
Month 96 (n=0,9,6)
|
NA number of copies/500 mg DNA
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
5.67 number of copies/500 mg DNA
Standard Deviation 6.69
|
17.67 number of copies/500 mg DNA
Standard Deviation 23.11
|
SECONDARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 and Follow-Up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
EBV DNA PCR categories included 0, 1-50, 51-100, 101-1000, and \>1000 copies/PCR.
Outcome measures
| Measure |
Tacrolimus
n=17 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=12 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
51-100: Month 54 (n=14,14,10)
|
0 percentage of participants
|
7.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
51-100: Month 78 (n=0,12,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
51-100: Month 84 (n=0,12,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
51-100: Month 90 (n=0,12,7)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
51-100: Month 96 (n=0,9,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
1-50: Follow-up (n=2,4,4)
|
0 percentage of participants
|
50.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
51-100: Month 9 (n=17,14,12)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
51-100: Month 48 (n=15,9,6)
|
0 percentage of participants
|
22.2 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
51-100: Month 12 (n=17,14,12)
|
0 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
51-100: Month 15 (n=17,14,12)
|
5.9 percentage of participants
|
7.1 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
51-100: Month 18 (n=17,13,12)
|
0 percentage of participants
|
7.7 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
51-100: Month 24 (n=15,13,12)
|
0 percentage of participants
|
7.7 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
51-100: Month 30 (n=13,14,10)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
51-100: Month 36 (n=15,14,8)
|
0 percentage of participants
|
7.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
51-100: Month 42 (n=14,12,9)
|
0 percentage of participants
|
8.3 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0: Month 9 (n=17,14,12)
|
88.2 percentage of participants
|
71.4 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0: Month 12 (n=17,14,12)
|
94.1 percentage of participants
|
64.3 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0: Month 15 (n=17,14,12)
|
88.2 percentage of participants
|
57.1 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0: Month 18 (n=17,13,12)
|
88.2 percentage of participants
|
53.8 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0: Month 24 (n=15,13,12)
|
100.0 percentage of participants
|
61.5 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0: Month 30 (n=13,14,10)
|
84.6 percentage of participants
|
42.9 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0: Month 36 (n=15,14,8)
|
86.7 percentage of participants
|
57.1 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0: Month 42 (n=14,12,9)
|
92.9 percentage of participants
|
33.3 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0: Month 48 (n=15,9,6)
|
93.3 percentage of participants
|
66.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0: Month 54 (n=14,14,10)
|
57.1 percentage of participants
|
50.0 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0: Month 60 (n=13,13,10)
|
76.9 percentage of participants
|
61.5 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0: Month 66 (n=10,13,9)
|
80.0 percentage of participants
|
38.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0: Month 72 (n=9,12,8)
|
88.9 percentage of participants
|
41.7 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0: Month 78 (n=0,12,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
41.7 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0: Month 84 (n=0,12,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
50.0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0: Month 90 (n=0,12,7)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
58.3 percentage of participants
|
42.9 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0: Month 96 (n=0,9,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
33.3 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0: Follow-up (n=2,4,4)
|
100.0 percentage of participants
|
50.0 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
1-50: Month 9 (n=17,14,12)
|
11.8 percentage of participants
|
28.6 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
1-50: Month 12 (n=17,14,12)
|
5.9 percentage of participants
|
35.7 percentage of participants
|
58.3 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
1-50: Month 18 (n=17,13,12)
|
11.8 percentage of participants
|
30.8 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
1-50: Month 24 (n=15,13,12)
|
0 percentage of participants
|
30.8 percentage of participants
|
58.3 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
1-50: Month 30 (n=13,14,10)
|
15.4 percentage of participants
|
50.0 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
1-50: Month 36 (n=15,14,8)
|
13.3 percentage of participants
|
35.7 percentage of participants
|
62.5 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
1-50: Month 42 (n=14,12,9)
|
7.1 percentage of participants
|
58.3 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
1-50: Month 48 (n=15,9,6)
|
6.7 percentage of participants
|
11.1 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
1-50: Month 54 (n=14,14,10)
|
42.9 percentage of participants
|
42.9 percentage of participants
|
70.0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
1-50: Month 60 (n=13,13,10)
|
23.1 percentage of participants
|
30.8 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
1-50: Month 66 (n=10,13,9)
|
20.0 percentage of participants
|
46.2 percentage of participants
|
55.6 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
1-50: Month 72 (n=9,12,8)
|
11.1 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
1-50: Month 78 (n=0,12,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
58.3 percentage of participants
|
62.5 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
1-50: Month 84 (n=0,12,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
50.0 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
1-50: Month 90 (n=0,12,7)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
41.7 percentage of participants
|
42.9 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
1-50: Month 96 (n=0,9,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
66.7 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
51-100: Month 60 (n=13,13,10)
|
0 percentage of participants
|
7.7 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
51-100: Month 66 (n=10,13,9)
|
0 percentage of participants
|
15.4 percentage of participants
|
44.4 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
51-100: Month 72 (n=9,12,8)
|
0 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
51-100: Follow-up (n=2,4,4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
101-1000: Month 9 (n=17,14,12)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
101-1000: Month 12 (n=17,14,12)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
101-1000: Month 15 (n=17,14,12)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
101-1000: Month 18 (n=17,13,12)
|
0 percentage of participants
|
7.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
101-1000: Month 24 (n=15,13,12)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
101-1000: Month 30 (n=13,14,10)
|
0 percentage of participants
|
7.1 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
101-1000: Month 36 (n=15,14,8)
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
101-1000: Month 42 (n=14,12,9)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
101-1000: Month 48 (n=15,9,6)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
101-1000: Month 54 (n=14,14,10)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
101-1000: Month 60 (n=13,13,10)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
101-1000: Month 66 (n=10,13,9)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
101-1000: Month 72 (n=9,12,8)
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
101-1000: Month 78 (n=0,12,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
101-1000: Month 84 (n=0,12,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
101-1000: Month 90 (n=0,12,7)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
101-1000: Month 96 (n=0,9,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
101-1000: Follow-up (n=2,4,4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
>1000: Month 9 (n=17,14,12)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
>1000: Month 12 (n=17,14,12)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
>1000: Month 15 (n=17,14,12)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
>1000: Month 18 (n=17,13,12)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
>1000: Month 24 (n=15,13,12)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
>1000: Month 30 (n=13,14,10)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
>1000: Month 36 (n=15,14,8)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
>1000: Month 42 (n=14,12,9)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
>1000: Month 48 (n=15,9,6)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
>1000: Month 54 (n=14,14,10)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
>1000: Month 60 (n=13,13,10)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
>1000: Month 66 (n=10,13,9)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
>1000: Month 72 (n=9,12,8)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
>1000: Month 78 (n=0,12,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
>1000: Month 84 (n=0,12,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
>1000: Month 90 (n=0,12,7)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
>1000: Month 96 (n=0,9,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
>1000: Follow-up (n=2,4,4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Calculated as number of copies per PCR. Per protocol, BKV DNA PCR was performed on tofacitinib-treated participants only.
Outcome measures
| Measure |
Tacrolimus
n=14 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=12 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
BK Virus (BKV) DNA Levels Determined Using PCR by Visit
Month 15 (n=13,12)
|
2.85 number of copies/PCR
Standard Deviation 7.66
|
0.75 number of copies/PCR
Standard Deviation 0.97
|
—
|
|
BK Virus (BKV) DNA Levels Determined Using PCR by Visit
Month 24 (n=2,1)
|
0.00 number of copies/PCR
Standard Deviation 0.00
|
0.00 number of copies/PCR
Standard Deviation NA
No measure of dispersion could be determined as only 1 participant was analyzed.
|
—
|
|
BK Virus (BKV) DNA Levels Determined Using PCR by Visit
Month 30 (n=0,1)
|
NA number of copies/PCR
Standard Deviation NA
No participants were analyzed for the parameter at the specified timepoint.
|
0.00 number of copies/PCR
Standard Deviation NA
No measure of dispersion could be determined as only 1 participant was analyzed.
|
—
|
|
BK Virus (BKV) DNA Levels Determined Using PCR by Visit
Month 36 (n=5,4)
|
15.80 number of copies/PCR
Standard Deviation 34.77
|
6.75 number of copies/PCR
Standard Deviation 13.50
|
—
|
|
BK Virus (BKV) DNA Levels Determined Using PCR by Visit
Month 42 (n=11,7)
|
0.64 number of copies/PCR
Standard Deviation 2.11
|
1.86 number of copies/PCR
Standard Deviation 4.49
|
—
|
|
BK Virus (BKV) DNA Levels Determined Using PCR by Visit
Month 54 (n=13,10)
|
4.54 number of copies/PCR
Standard Deviation 14.66
|
1.40 number of copies/PCR
Standard Deviation 3.78
|
—
|
|
BK Virus (BKV) DNA Levels Determined Using PCR by Visit
Month 60 (n=13,7)
|
15.85 number of copies/PCR
Standard Deviation 41.81
|
0.86 number of copies/PCR
Standard Deviation 2.27
|
—
|
|
BK Virus (BKV) DNA Levels Determined Using PCR by Visit
Month 9 (n=14,12)
|
1.29 number of copies/PCR
Standard Deviation 4.53
|
1.58 number of copies/PCR
Standard Deviation 2.84
|
—
|
|
BK Virus (BKV) DNA Levels Determined Using PCR by Visit
Month 12 (n=13,10)
|
2.23 number of copies/PCR
Standard Deviation 3.81
|
0.10 number of copies/PCR
Standard Deviation 0.32
|
—
|
|
BK Virus (BKV) DNA Levels Determined Using PCR by Visit
Month 18 (n=7,8)
|
0.14 number of copies/PCR
Standard Deviation 0.38
|
0.38 number of copies/PCR
Standard Deviation 0.74
|
—
|
|
BK Virus (BKV) DNA Levels Determined Using PCR by Visit
Month 48 (n=9,6)
|
8.33 number of copies/PCR
Standard Deviation 23.18
|
3.33 number of copies/PCR
Standard Deviation 8.16
|
—
|
|
BK Virus (BKV) DNA Levels Determined Using PCR by Visit
Month 66 (n=13,8)
|
6.15 number of copies/PCR
Standard Deviation 21.00
|
0.00 number of copies/PCR
Standard Deviation 0.00
|
—
|
|
BK Virus (BKV) DNA Levels Determined Using PCR by Visit
Month 72 (n=10,7)
|
1.00 number of copies/PCR
Standard Deviation 2.83
|
0.14 number of copies/PCR
Standard Deviation 0.38
|
—
|
|
BK Virus (BKV) DNA Levels Determined Using PCR by Visit
Month 78 (n=9,7)
|
0.56 number of copies/PCR
Standard Deviation 1.13
|
0.14 number of copies/PCR
Standard Deviation 0.38
|
—
|
|
BK Virus (BKV) DNA Levels Determined Using PCR by Visit
Month 84 (n=10,7)
|
0.60 number of copies/PCR
Standard Deviation 1.90
|
0.14 number of copies/PCR
Standard Deviation 0.38
|
—
|
|
BK Virus (BKV) DNA Levels Determined Using PCR by Visit
Month 90 (n=9,4)
|
0.56 number of copies/PCR
Standard Deviation 1.67
|
0.00 number of copies/PCR
Standard Deviation 0.00
|
—
|
|
BK Virus (BKV) DNA Levels Determined Using PCR by Visit
Month 96 (n=9,3)
|
1.11 number of copies/PCR
Standard Deviation 2.67
|
0.00 number of copies/PCR
Standard Deviation 0.00
|
—
|
|
BK Virus (BKV) DNA Levels Determined Using PCR by Visit
Follow-up (n=3,2)
|
0.00 number of copies/PCR
Standard Deviation 0.00
|
0.50 number of copies/PCR
Standard Deviation 0.71
|
—
|
SECONDARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Cutoff categories for BKV DNA were 0-199 and ≥200 copies/PCR. Per protocol, BKV DNA PCR was performed on tofacitinib-treated participants only.
Outcome measures
| Measure |
Tacrolimus
n=14 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=12 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
≥200: Month 72 (n=10,7)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0-199: Month 9 (n=14,12)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0-199: Month 12 (n=13,10)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0-199: Month 15 (n=13,12)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0-199: Month 18 (n=7,8)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0-199: Month 24 (n=2,1)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0-199: Month 30 (n=0,1)
|
0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0-199: Month 36 (n=5,4)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0-199: Month 42 (n=11,7)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0-199: Month 48 (n=9,6)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0-199: Month 54 (n=13,10)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0-199: Month 60 (n=13,7)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0-199: Month 66 (n=13,8)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0-199: Month 72 (n=10,7)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0-199: Month 78 (n=9,7)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0-199: Month 84 (n=10,7)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0-199: Month 90 (n=9,4)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0-199: Month 96 (n=9,3)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
0-199: Follow-up (n=3,2)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
≥200: Month 9 (n=14,12)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
≥200: Month 12 (n=13,10)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
≥200: Month 15 (n=13,12)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
≥200: Month 18 (n=7,8)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
≥200: Month 24 (n=2,1)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
≥200: Month 30 (n=0,1)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
≥200: Month 36 (n=5,4)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
≥200: Month 42 (n=11,7)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
≥200: Month 48 (n=9,6)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
≥200: Month 54 (n=13,10)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
≥200: Month 60 (n=13,7)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
≥200: Month 66 (n=13,8)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
≥200: Month 78 (n=9,7)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
≥200: Month 84 (n=10,7)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
≥200: Month 90 (n=9,4)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
≥200: Month 96 (n=9,3)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
≥200: Follow-up (n=3,2)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96Population: Safety population; n=number of participants remaining at risk for the specified parameter at a given visit.
Kaplan-Meier analysis of percentage of participants with CMV disease within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. CMV disease was an adverse event associated with the preferred term 'CMV infection'.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=13 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Month 96 (n=0,12,7)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
7.14 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Month 72 (n=5,13,8)
|
5.56 percentage of participants
|
7.14 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Month 84 (n=0,12,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
7.14 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Month 12 (n=18,13,12)
|
0.00 percentage of participants
|
7.14 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Month 15 (n=17,13,12)
|
5.56 percentage of participants
|
7.14 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Month 18 (n=16,13,12)
|
5.56 percentage of participants
|
7.14 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Month 24 (n=16,13,12)
|
5.56 percentage of participants
|
7.14 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Month 30 (n=14,13,11)
|
5.56 percentage of participants
|
7.14 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Month 36 (n=14,13,11)
|
5.56 percentage of participants
|
7.14 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Month 66 (n=12,13,9)
|
5.56 percentage of participants
|
7.14 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Month 42 (n=14,13,10)
|
5.56 percentage of participants
|
7.14 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Month 48 (n=13,13,10)
|
5.56 percentage of participants
|
7.14 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Month 78 (n=0,13,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
7.14 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Month 90 (n=0,12,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
7.14 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Month 54 (n=13,13,10)
|
5.56 percentage of participants
|
7.14 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Month 60 (n=12,13,10)
|
5.56 percentage of participants
|
7.14 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Day 1 (n=18,14,13)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Month 1 (n=18,14,13)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Month 3 (n=18,14,12)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Month 6 (n=18,14,12)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Month 9 (n=18,13,12)
|
0.00 percentage of participants
|
7.14 percentage of participants
|
7.69 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96Population: FAS; n=number of participants remaining at risk for the specified parameter at a given visit.
Kaplan-Meier analysis of percentage of participants with first BPCAN by time to first BPCAN within 96 months post-transplant. BPCAN was defined as chronic allograft nephropathy (Category 5 of the Banff Classification), based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Includes BPCAN diagnosed on biopsies done for cause and ready by the central pathologist.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=13 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Month 24 (n=17,14,11)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Month 78 (n=0,14,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Day 1 (n=18,14,13)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Month 1 (n=18,14,13)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Month 3 (n=18,14,12)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Month 6 (n=18,14,12)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Month 9 (n=18,14,12)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Month 12 (n=18,14,12)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Month 15 (n=18,14,12)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Month 18 (n=17,14,12)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
7.69 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Month 30 (n=15,14,10)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Moth 36 (n=15,14,10)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Month 42 (n=15,14,9)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Month 48 (n=14,14,9)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Month 54 (n=14,14,9)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Month 60 (n=13,14,9)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Month 66 (n=13,14,8)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Month 72 (n=6,14,7)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Month 84 (n=0,13,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Month 90 (n=0,13,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Month 96 (n=0,12,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0.00 percentage of participants
|
15.38 percentage of participants
|
SECONDARY outcome
Timeframe: Months 12, 18, 24, 36, 48, 60, 72, 84, 96, and Follow-Up (Month 98)Population: FAS
Antibody-mediated rejection is defined as Category 2 and BPAR is defined as Category 4 of the Banff Classification, based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Acute humoral rejection was categorized as Grades I, II, III and acute/active cellular rejection was categorized as Grades IA, IB, IIA, IIB, and III. Only participants with first BPAR were included.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=13 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR
Month 18 BPAR (n=18,14,13)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR
Month 24 Antibody-mediated rejection (n=18,14,13)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR
Month 36 Antibody-mediated rejection (n=18,14,13)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR
Month 48 Antibody-mediated rejection (n=18,14,13)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR
Month 60 Antibody-mediated rejection (n=18,14,13)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR
Month 72 Antibody-mediated rejection (n=18,14,13)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR
Month 84 Antibody-mediated rejection (n=18,14,13)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR
Month 36 BPAR (n=18,14,13)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR
Month 72 BPAR (n=18,14,13)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR
Month 84 BPAR (n=18,14,13)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR
Month 48 BPAR (n=18,14,13)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR
Month 60 BPAR (n=18,14,13)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR
Month 96 BPAR (n=18,14,13)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR
Follow-up BPAR (n=18,14,13)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR
Month 12 Antibody-mediated rejection (n=18,14,13)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR
Month 18 Antibody-mediated rejection (n=18,14,13)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR
Month 96 Antibody-mediated rejection (n=18,14,13)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR
Follow-up Antibody-mediated rejection (n=18,14,13)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR
Month 12 BPAR (n=18,14,13)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR
Month 24 BPAR (n=18,14,13)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Months 12, 18, 24, 36, 48, 60, 72, 84, and 96Population: FAS
Ordered categorical severity of first BPCAN was classified according to the Banff Classification. Grade I: mild, grade II: moderate and grade III: severe interstitial fibrosis and tubular atrophy/loss. (Racusen et al: The Banff classification, 1999).
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=13 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 12: Grade II
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 12: Grade III
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 18: Grade II
|
0 percentage of participants
|
0 percentage of participants
|
7.7 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 18: Grade III
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 48: Grade I
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 48: Grade II
|
0 percentage of participants
|
0 percentage of participants
|
7.7 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 48: Grade III
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 60: Grade I
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 60: Grade II
|
0 percentage of participants
|
0 percentage of participants
|
7.7 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 60: Grade III
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 72: Grade II
|
0 percentage of participants
|
0 percentage of participants
|
7.7 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 96: Grade II
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0 percentage of participants
|
7.7 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 12: Grade I
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 18: Grade I
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 24: Grade I
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 24: Grade II
|
0 percentage of participants
|
0 percentage of participants
|
7.7 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 24: Grade III
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 36: Grade I
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 36: Grade II
|
0 percentage of participants
|
0 percentage of participants
|
7.7 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 36: Grade III
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 72: Grade I
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 72: Grade III
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 84: Grade I
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 84: Grade II
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0 percentage of participants
|
7.7 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 84: Grade III
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 96: Grade I
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Month 96: Grade III
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96Population: FAS; n=number of participants remaining at risk for the specified parameter at a given visit.
Kaplan-Meier analysis of percentage of participants with efficacy failure by time to first efficacy failure within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Efficacy failure was defined as first occurrence of BPAR, death, or graft loss.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=13 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 1 (n=17,14,13)
|
5.56 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 3 (n=17,14,11)
|
5.56 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 6 (n=17,14,11)
|
5.56 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 9 (n=16,14,11)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 12 (n=16,14,11)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 18 (n=16,14,11)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 24 (n=16,14,11)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 36 (n=14,14,10)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 54 (n=13,14,9)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 84 (n=0,13,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
7.14 percentage of participants
|
25.96 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 90 (n=0,13,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
7.14 percentage of participants
|
25.96 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 96 (n=0,12,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
7.14 percentage of participants
|
25.96 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Day 1 (n=18,14,13)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 15 (n=16,14,11)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 30 (n=14,14,10)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 42 (n=14,14,9)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 48 (n=13,14,9)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 60 (n=12,14,9)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 66 (n=12,14,8)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 72 (n=5,14,7)
|
11.11 percentage of participants
|
0.00 percentage of participants
|
25.96 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Month 78 (n=0,14,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
0.00 percentage of participants
|
25.96 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96Population: FAS; n=number of participants remaining at risk for the specified parameter at a given visit.
Kaplan-Meier analysis of percentage of participants with graft survival by time to graft loss within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Graft loss was defined as graft nephrectomy, retransplantation, return to dialysis for ≥6 consecutive weeks, or death.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=13 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Day 1 (n=18,14,13)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Month 1 (n=18,14,13)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Month 3 (n=18,14,13)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Month 6 (n=18,14,13)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Month 9 (n=18,14,13)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Month 15 (n=18,14,13)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Month 18 (n=17,14,13)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Month 24 (n=17,14,13)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Month 30 (n=15,14,12)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Month 36 (n=15,14,12)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Month 48 (n=14,14,11)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Month 54 (n=14,14,11)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Month 66 (n=13,14,10)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Month 72 (n=6,14,9)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
90.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Month 84 (n=0,13,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
92.86 percentage of participants
|
90.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Month 90 (n=0,13,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
92.86 percentage of participants
|
90.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Month 12 (n=18,14,13)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Month 42 (n=15,14,11)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Month 60 (n=13,14,11)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Month 78 (n=0,14,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
100.00 percentage of participants
|
90.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Month 96 (n=0,12,7)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
92.86 percentage of participants
|
90.00 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96Population: FAS; n=number of participants remaining at risk for the specified parameter at a given visit.
Kaplan-Meier analysis of percentage of participants surviving by time to event (death) within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=13 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 36 (n=15,14,12)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 42 (n=15,14,11)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 72 (n=6,14,9)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
90.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 96 (n=0,12,7)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
92.86 percentage of participants
|
90.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Day 1 (n=18,14,13)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 1 (n=18,14,13)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 3 (n=18,14,13)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 6 (n=18,14,13)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 9 (n=18,14,13)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 12 (n=18,14,13)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 15 (n=18,14,13)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 18 (n=17,14,13)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 24 (n=17,14,13)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 30 (n=15,14,12)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 48 (n=14,14,11)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 54 (n=14,14,11)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 60 (n=13,14,11)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 66 (n=13,14,10)
|
100.00 percentage of participants
|
100.00 percentage of participants
|
100.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 78 (n=0,14,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
100.00 percentage of participants
|
90.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 84 (n=0,13,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
92.86 percentage of participants
|
90.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Month 90 (n=0,13,8)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
92.86 percentage of participants
|
90.00 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96Population: FAS; n=number of participants remaining at risk for the specified parameter at a given visit.
Kaplan-Meier analysis of percentage of participants with rejection by time to rejection within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Rejection was defined as first occurrence of BPAR, antibody-mediated rejection or suspicious for acute rejection. This included biopsies read by the central pathologist.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=13 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Month 1 (n=17,13,13)
|
5.56 percentage of participants
|
7.14 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Month 3 (n=17,13,11)
|
5.56 percentage of participants
|
7.14 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Month 6 (n=17,13,11)
|
5.56 percentage of participants
|
7.14 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Month 18 (n=16,13,11)
|
11.11 percentage of participants
|
7.14 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Month 24 (n=16,13,11)
|
11.11 percentage of participants
|
7.14 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Month 36 (n=14,13,10)
|
11.11 percentage of participants
|
7.14 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Month 54 (n=13,13,9)
|
11.11 percentage of participants
|
7.14 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Month 84 (n=0,12,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
7.14 percentage of participants
|
27.47 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Day 1 (n=18,14,13)
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Month 9 (n=16,13,11)
|
11.11 percentage of participants
|
7.14 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Month 12 (n=16,13,11)
|
11.11 percentage of participants
|
7.14 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Month 15 (n=16,13,11)
|
11.11 percentage of participants
|
7.14 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Month 30 (n=14,13,10)
|
11.11 percentage of participants
|
7.14 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Month 42 (n=14,13,9)
|
11.11 percentage of participants
|
7.14 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Month 48 (n=13,13,9)
|
11.11 percentage of participants
|
7.14 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Month 60 (n=12,13,9)
|
11.11 percentage of participants
|
7.14 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Month 66 (n=12,13,8)
|
11.11 percentage of participants
|
7.14 percentage of participants
|
15.38 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Month 72 (n=5,13,6)
|
11.11 percentage of participants
|
7.14 percentage of participants
|
27.47 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Month 78 (n=0,13,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
7.14 percentage of participants
|
27.47 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Month 90 (n=0,12,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
7.14 percentage of participants
|
27.47 percentage of participants
|
|
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Month 96 (n=0,11,6)
|
NA percentage of participants
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
7.14 percentage of participants
|
27.47 percentage of participants
|
SECONDARY outcome
Timeframe: Months 12 and 24Population: Safety population
Outcome measures
| Measure |
Tacrolimus
n=15 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=12 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit
CD8+: Month 24
|
318.20 cells/uL
Standard Deviation 183.85
|
224.36 cells/uL
Standard Deviation 194.45
|
238.08 cells/uL
Standard Deviation 172.46
|
|
Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit
CD19+: Month 12
|
197.53 cells/uL
Standard Deviation 209.42
|
169.64 cells/uL
Standard Deviation 97.97
|
127.42 cells/uL
Standard Deviation 67.08
|
|
Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit
CD4+: Month 12
|
612.80 cells/uL
Standard Deviation 339.75
|
634.86 cells/uL
Standard Deviation 280.75
|
565.00 cells/uL
Standard Deviation 222.61
|
|
Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit
CD8+: Month 12
|
284.67 cells/uL
Standard Deviation 218.43
|
207.43 cells/uL
Standard Deviation 97.19
|
232.33 cells/uL
Standard Deviation 110.61
|
|
Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit
CD19+: Month 24
|
144.47 cells/uL
Standard Deviation 116.77
|
125.86 cells/uL
Standard Deviation 79.56
|
85.08 cells/uL
Standard Deviation 51.02
|
|
Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit
CD4+: Month 24
|
599.13 cells/uL
Standard Deviation 216.61
|
462.00 cells/uL
Standard Deviation 295.73
|
457.83 cells/uL
Standard Deviation 202.29
|
|
Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit
CD56+: Month 12
|
152.67 cells/uL
Standard Deviation 198.33
|
50.14 cells/uL
Standard Deviation 43.96
|
35.58 cells/uL
Standard Deviation 30.60
|
|
Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit
CD56+: Month 24
|
135.27 cells/uL
Standard Deviation 145.25
|
77.86 cells/uL
Standard Deviation 107.37
|
59.17 cells/uL
Standard Deviation 69.31
|
SECONDARY outcome
Timeframe: Months 12, 24, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 and Follow-up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Outcome measures
| Measure |
Tacrolimus
n=16 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=12 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Hemoglobin A1c (HbA1c) Levels by Visit
Month 12 (n=16,14,12)
|
5.65 % HbA1c
Standard Deviation 0.69
|
6.84 % HbA1c
Standard Deviation 2.04
|
6.02 % HbA1c
Standard Deviation 0.82
|
|
Hemoglobin A1c (HbA1c) Levels by Visit
Month 24 (n=16,14,12)
|
5.63 % HbA1c
Standard Deviation 0.68
|
7.12 % HbA1c
Standard Deviation 2.20
|
6.28 % HbA1c
Standard Deviation 1.24
|
|
Hemoglobin A1c (HbA1c) Levels by Visit
Month 36 (n=15,14,8)
|
5.75 % HbA1c
Standard Deviation 1.21
|
7.19 % HbA1c
Standard Deviation 2.44
|
6.56 % HbA1c
Standard Deviation 1.35
|
|
Hemoglobin A1c (HbA1c) Levels by Visit
Month 42 (n=15,14,9)
|
5.81 % HbA1c
Standard Deviation 1.08
|
7.40 % HbA1c
Standard Deviation 2.56
|
6.68 % HbA1c
Standard Deviation 1.64
|
|
Hemoglobin A1c (HbA1c) Levels by Visit
Month 48 (n=15,14,10)
|
6.03 % HbA1c
Standard Deviation 1.23
|
7.25 % HbA1c
Standard Deviation 2.37
|
6.25 % HbA1c
Standard Deviation 0.82
|
|
Hemoglobin A1c (HbA1c) Levels by Visit
Month 54 (n=14,14,10)
|
6.39 % HbA1c
Standard Deviation 1.86
|
7.25 % HbA1c
Standard Deviation 1.94
|
6.43 % HbA1c
Standard Deviation 1.28
|
|
Hemoglobin A1c (HbA1c) Levels by Visit
Month 60 (n=12,12,10)
|
6.18 % HbA1c
Standard Deviation 1.11
|
7.03 % HbA1c
Standard Deviation 1.75
|
6.48 % HbA1c
Standard Deviation 1.47
|
|
Hemoglobin A1c (HbA1c) Levels by Visit
Month 66 (n=12,14,10)
|
6.13 % HbA1c
Standard Deviation 1.29
|
6.99 % HbA1c
Standard Deviation 1.82
|
6.52 % HbA1c
Standard Deviation 1.59
|
|
Hemoglobin A1c (HbA1c) Levels by Visit
Month 72 (n=9,12,8)
|
6.31 % HbA1c
Standard Deviation 1.72
|
6.93 % HbA1c
Standard Deviation 1.88
|
6.29 % HbA1c
Standard Deviation 1.38
|
|
Hemoglobin A1c (HbA1c) Levels by Visit
Month 78 (n=12,8)
|
NA % HbA1c
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
7.27 % HbA1c
Standard Deviation 2.52
|
6.43 % HbA1c
Standard Deviation 1.98
|
|
Hemoglobin A1c (HbA1c) Levels by Visit
Month 84 (n=12,8)
|
NA % HbA1c
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
6.66 % HbA1c
Standard Deviation 1.85
|
5.99 % HbA1c
Standard Deviation 1.00
|
|
Hemoglobin A1c (HbA1c) Levels by Visit
Month 90 (n=12,7)
|
NA % HbA1c
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
6.38 % HbA1c
Standard Deviation 1.80
|
6.54 % HbA1c
Standard Deviation 2.08
|
|
Hemoglobin A1c (HbA1c) Levels by Visit
Month 96 (n=11,6)
|
NA % HbA1c
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
6.32 % HbA1c
Standard Deviation 1.42
|
6.77 % HbA1c
Standard Deviation 2.44
|
|
Hemoglobin A1c (HbA1c) Levels by Visit
Follow-up (n=3,13,6)
|
6.50 % HbA1c
Standard Deviation 2.00
|
6.65 % HbA1c
Standard Deviation 1.76
|
7.22 % HbA1c
Standard Deviation 2.71
|
SECONDARY outcome
Timeframe: Months 12 and 24Population: Safety population; n=number of participants who were eligible for OGTT and had data (non-missing) at that particular visit.
HOMA-%B = (20 times \[\*\] fasting serum insulin) divided by (/) (fasting serum glucose minus \[-\] 3.5). HOMA-%B was only performed in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin prior to the time of measurements.
Outcome measures
| Measure |
Tacrolimus
n=9 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=6 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=5 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Homeostatic Model Assessment (HOMA)-%B by Visit
Month 12 (n=8,6,5)
|
204.67 %B
Standard Deviation 195.58
|
142.23 %B
Standard Deviation 95.06
|
194.65 %B
Standard Deviation 131.16
|
|
Homeostatic Model Assessment (HOMA)-%B by Visit
Month 24 (n=9,6,5)
|
224.75 %B
Standard Deviation 333.49
|
138.10 %B
Standard Deviation 89.84
|
165.38 %B
Standard Deviation 68.73
|
SECONDARY outcome
Timeframe: Months 12 and 24Population: Safety population; n=number of participants eligible for OGTT and had data (non-missing) at that particular visit.
Measured only in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin prior to the time of measurement.
Outcome measures
| Measure |
Tacrolimus
n=5 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=4 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=2 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Ratio of Fasting Serum Proinsulin (Pmol/L) to Insulin (Pmol/L) by Visit
Month 12 (n=5,3,3)
|
0.15 ratio of serum proinsulin to insulin
Standard Deviation 0.07
|
0.32 ratio of serum proinsulin to insulin
Standard Deviation 0.04
|
0.40 ratio of serum proinsulin to insulin
Standard Deviation 0.31
|
|
Ratio of Fasting Serum Proinsulin (Pmol/L) to Insulin (Pmol/L) by Visit
Month 24 (n=3,4,2)
|
0.64 ratio of serum proinsulin to insulin
Standard Deviation 0.42
|
0.30 ratio of serum proinsulin to insulin
Standard Deviation 0.20
|
0.22 ratio of serum proinsulin to insulin
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: Months 12 and 24Population: Safety population; n=number of participants eligible for OGTT with data (non-missing) at that particular visit.
Only performed in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin.
Outcome measures
| Measure |
Tacrolimus
n=12 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=8 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=6 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Area Under the Curve (AUC) of Serum Glucose (mg*h/dL) Measured During Oral Glucose Tolerance Test (OGTT) by Visit
Month 12 (n=10,6,6)
|
234.78 mg*h/dL
Standard Deviation 58.78
|
254.25 mg*h/dL
Standard Deviation 72.34
|
281.54 mg*h/dL
Standard Deviation 52.39
|
|
Area Under the Curve (AUC) of Serum Glucose (mg*h/dL) Measured During Oral Glucose Tolerance Test (OGTT) by Visit
Month 24 (n=12,8,5)
|
230.10 mg*h/dL
Standard Deviation 56.41
|
236.94 mg*h/dL
Standard Deviation 92.98
|
281.90 mg*h/dL
Standard Deviation 100.76
|
SECONDARY outcome
Timeframe: Months 12 and 24Population: Safety population: n=number of participants who were eligible for OGTT and had data (non-mising) at that particular visit.
The OGTT was performed only in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin.
Outcome measures
| Measure |
Tacrolimus
n=10 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=6 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=6 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
AUC of Serum Insulin (microU*h/mL) Measured During OGTT by Visit
Month 12 (n=10,6,6)
|
85.05 microU*h/mL
Standard Deviation 37.57
|
99.96 microU*h/mL
Standard Deviation 54.22
|
153.46 microU*h/mL
Standard Deviation 92.11
|
|
AUC of Serum Insulin (microU*h/mL) Measured During OGTT by Visit
Month 24 (n=8,6,5)
|
79.84 microU*h/mL
Standard Deviation 42.65
|
130.63 microU*h/mL
Standard Deviation 48.07
|
181.70 microU*h/mL
Standard Deviation 155.32
|
SECONDARY outcome
Timeframe: Months 12 and 24Population: Safety population; n=number of participants who were eligible for OGTT and had data (non-mising) at that particular visit.
HOMA-IR=fasting serum insulin\*fasting serum glucose/22.5. Measurement only performed in participants who were non-diabetic prior to kidney transplantation and who do not require treatment with oral hypoglycemic agents, anti diabetic agents, and/or insulin prior to the time of measurement.
Outcome measures
| Measure |
Tacrolimus
n=9 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=6 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=5 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
HOMA Insulin Resistance (IR) by Visit
Month 12 (n=8,6,5)
|
2.55 HOMA-IR
Standard Deviation 1.49
|
2.24 HOMA-IR
Standard Deviation 1.85
|
2.54 HOMA-IR
Standard Deviation 1.51
|
|
HOMA Insulin Resistance (IR) by Visit
Month 24 (n=9,6,5)
|
2.67 HOMA-IR
Standard Deviation 2.76
|
9.01 HOMA-IR
Standard Deviation 18.37
|
2.68 HOMA-IR
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Outcome measures
| Measure |
Tacrolimus
n=18 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=12 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Fasting Serum Glucose Levels (mg/dL) by Visit
Month 90 (n=0,11,7)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
114.55 mg/dL
Standard Deviation 33.39
|
96.43 mg/dL
Standard Deviation 16.83
|
|
Fasting Serum Glucose Levels (mg/dL) by Visit
Month 9 (n=18,14,10)
|
96.89 mg/dL
Standard Deviation 18.78
|
115.14 mg/dL
Standard Deviation 42.16
|
97.90 mg/dL
Standard Deviation 19.44
|
|
Fasting Serum Glucose Levels (mg/dL) by Visit
Month 12 (n=17,14,12)
|
103.00 mg/dL
Standard Deviation 26.25
|
133.79 mg/dL
Standard Deviation 51.07
|
102.75 mg/dL
Standard Deviation 35.70
|
|
Fasting Serum Glucose Levels (mg/dL) by Visit
Month 15 (n=17,13,11)
|
95.41 mg/dL
Standard Deviation 20.99
|
128.08 mg/dL
Standard Deviation 85.36
|
99.18 mg/dL
Standard Deviation 33.34
|
|
Fasting Serum Glucose Levels (mg/dL) by Visit
Month 18 (n=18,14,12)
|
94.72 mg/dL
Standard Deviation 21.38
|
117.93 mg/dL
Standard Deviation 51.81
|
112.50 mg/dL
Standard Deviation 48.45
|
|
Fasting Serum Glucose Levels (mg/dL) by Visit
Month 24 (n=17,14,12)
|
113.71 mg/dL
Standard Deviation 32.54
|
115.64 mg/dL
Standard Deviation 45.68
|
122.25 mg/dL
Standard Deviation 33.94
|
|
Fasting Serum Glucose Levels (mg/dL) by Visit
Month 30 (n=14,14,10)
|
102.50 mg/dL
Standard Deviation 29.02
|
137.86 mg/dL
Standard Deviation 77.07
|
140.00 mg/dL
Standard Deviation 79.88
|
|
Fasting Serum Glucose Levels (mg/dL) by Visit
Month 36 (n=15,14,9)
|
108.20 mg/dL
Standard Deviation 39.01
|
128.00 mg/dL
Standard Deviation 54.34
|
143.33 mg/dL
Standard Deviation 76.69
|
|
Fasting Serum Glucose Levels (mg/dL) by Visit
Month 42 (n=15,14,9)
|
104.47 mg/dL
Standard Deviation 30.92
|
113.71 mg/dL
Standard Deviation 47.34
|
109.56 mg/dL
Standard Deviation 34.93
|
|
Fasting Serum Glucose Levels (mg/dL) by Visit
Month 48 (n=15,14,10)
|
112.93 mg/dL
Standard Deviation 49.35
|
123.29 mg/dL
Standard Deviation 77.74
|
98.00 mg/dL
Standard Deviation 13.80
|
|
Fasting Serum Glucose Levels (mg/dL) by Visit
Month 54 (n=12,14,10)
|
126.58 mg/dL
Standard Deviation 81.04
|
119.21 mg/dL
Standard Deviation 50.14
|
116.30 mg/dL
Standard Deviation 69.12
|
|
Fasting Serum Glucose Levels (mg/dL) by Visit
Month 60 (n=12,12,10)
|
107.08 mg/dL
Standard Deviation 22.95
|
136.17 mg/dL
Standard Deviation 68.68
|
111.70 mg/dL
Standard Deviation 34.86
|
|
Fasting Serum Glucose Levels (mg/dL) by Visit
Month 66 (n=10,13,10)
|
111.90 mg/dL
Standard Deviation 36.39
|
143.77 mg/dL
Standard Deviation 103.15
|
112.90 mg/dL
Standard Deviation 48.43
|
|
Fasting Serum Glucose Levels (mg/dL) by Visit
Month 72 (n=9,13,7)
|
100.44 mg/dL
Standard Deviation 39.41
|
117.69 mg/dL
Standard Deviation 61.22
|
127.43 mg/dL
Standard Deviation 74.82
|
|
Fasting Serum Glucose Levels (mg/dL) by Visit
Month 78 (n=0,12,8)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
131.67 mg/dL
Standard Deviation 66.25
|
98.50 mg/dL
Standard Deviation 30.07
|
|
Fasting Serum Glucose Levels (mg/dL) by Visit
Month 84 (n=0,12,6)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
139.50 mg/dL
Standard Deviation 86.88
|
112.50 mg/dL
Standard Deviation 50.12
|
|
Fasting Serum Glucose Levels (mg/dL) by Visit
Month 96 (n=0,11,6)
|
NA mg/dL
Standard Deviation NA
The tacrolimus treatment group was discontinued after Month 72, thus no participants were analyzed for this parameter at this timepoint.
|
154.64 mg/dL
Standard Deviation 115.73
|
100.33 mg/dL
Standard Deviation 15.65
|
|
Fasting Serum Glucose Levels (mg/dL) by Visit
Follow-up (n=6,10,7)
|
112.17 mg/dL
Standard Deviation 42.96
|
126.30 mg/dL
Standard Deviation 75.84
|
98.86 mg/dL
Standard Deviation 31.73
|
SECONDARY outcome
Timeframe: Months 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Outcome measures
| Measure |
Tacrolimus
n=14 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=12 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Follow-up, 0.5 hours postdose (n=2,4)
|
2.57 ng/mL
Standard Deviation 2.23
|
5.39 ng/mL
Standard Deviation 5.28
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 9, predose (n=13,11)
|
40.97 ng/mL
Standard Deviation 46.65
|
12.38 ng/mL
Standard Deviation 7.60
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 9, 0.5 hours postdose (n=0,1)
|
NA ng/mL
Standard Deviation NA
No participants were analyzed for the parameter at the specified timepoint.
|
24.00 ng/mL
Standard Deviation NA
No measure of dispersion could be determined as only 1 participant was analyzed.
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 12, predose (n=13,12)
|
14.75 ng/mL
Standard Deviation 10.44
|
32.86 ng/mL
Standard Deviation 46.50
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 12, 1 hour postdose (n=1,0)
|
51.50 ng/mL
Standard Deviation NA
No measure of dispersion could be determined as only 1 participant was analyzed.
|
NA ng/mL
Standard Deviation NA
No participants were analyzed for the parameter at the specified timepoint.
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 18, predose (n=12,10)
|
13.77 ng/mL
Standard Deviation 10.60
|
7.84 ng/mL
Standard Deviation 7.37
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 18, 0.5 hours postdose (n=0,1)
|
NA ng/mL
Standard Deviation NA
No participants were analyzed for the parameter at the specified timepoint.
|
86.30 ng/mL
Standard Deviation NA
No measure of dispersion could be determined as only 1 participant was analyzed.
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 18, 1 hour postdose (n=0,1)
|
NA ng/mL
Standard Deviation NA
No participants were analyzed for the parameter at the specified timepoint.
|
80.70 ng/mL
Standard Deviation NA
No measure of dispersion could be determined as only 1 participant was analyzed.
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 24, predose (n=14,12)
|
15.43 ng/mL
Standard Deviation 11.14
|
28.15 ng/mL
Standard Deviation 45.77
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 24, 0.5 hours postdose (n=5,2)
|
28.02 ng/mL
Standard Deviation 4.44
|
96.30 ng/mL
Standard Deviation 32.10
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 24, 1 hour postdose (n=6,3)
|
40.88 ng/mL
Standard Deviation 9.28
|
72.33 ng/mL
Standard Deviation 35.80
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 30, predose (n=14,9)
|
6.53 ng/mL
Standard Deviation 5.37
|
16.18 ng/mL
Standard Deviation 19.46
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 30, 0.5 hours postdose (n=5,2)
|
51.44 ng/mL
Standard Deviation 26.39
|
54.95 ng/mL
Standard Deviation 16.05
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 30, 1 hour postdose (n=5,2)
|
57.78 ng/mL
Standard Deviation 10.90
|
98.45 ng/mL
Standard Deviation 30.48
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 36, predose (n=14,8)
|
6.73 ng/mL
Standard Deviation 4.49
|
13.28 ng/mL
Standard Deviation 9.88
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 42, predose (n=14, 8)
|
19.70 ng/mL
Standard Deviation 29.98
|
22.01 ng/mL
Standard Deviation 13.71
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 48, predose (n=12,9)
|
9.71 ng/mL
Standard Deviation 6.51
|
15.54 ng/mL
Standard Deviation 7.33
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 48, 0.5 hours postdose (n=1,1)
|
1.00 ng/mL
Standard Deviation NA
No measure of dispersion could be determined as only 1 participant was analyzed.
|
55.70 ng/mL
Standard Deviation NA
No measure of dispersion could be determined as only 1 participant was analyzed.
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 48, 1 hour postdose (n=1,0)
|
56.60 ng/mL
Standard Deviation NA
No measure of dispersion could be determined as only 1 participant was analyzed.
|
NA ng/mL
Standard Deviation NA
No participants were analyzed for the parameter at the specified timepoint.
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 54, predose (n=14,10)
|
15.99 ng/mL
Standard Deviation 14.97
|
24.74 ng/mL
Standard Deviation 41.68
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 60, predose (n=11,10)
|
10.69 ng/mL
Standard Deviation 9.62
|
15.03 ng/mL
Standard Deviation 10.78
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 60, 0.5 hours postdose (n=1,0)
|
41.10 ng/mL
Standard Deviation NA
No measure of dispersion could be determined as only 1 participant was analyzed.
|
NA ng/mL
Standard Deviation NA
No participants were analyzed for the parameter at the specified timepoint.
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 66, predose (n=11,10)
|
14.64 ng/mL
Standard Deviation 15.04
|
22.78 ng/mL
Standard Deviation 18.11
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 66, 0.5 hours postdose (n=1,2)
|
27.70 ng/mL
Standard Deviation NA
No measure of dispersion could be determined as only 1 participant was analyzed.
|
29.75 ng/mL
Standard Deviation 18.17
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 66, 1 hour postdose (n=1,1)
|
18.90 ng/mL
Standard Deviation NA
No measure of dispersion could be determined as only 1 participant was analyzed.
|
29.10 ng/mL
Standard Deviation NA
No measure of dispersion could be determined as only 1 participant was analyzed.
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 72, predose (n=9,7)
|
10.07 ng/mL
Standard Deviation 14.63
|
20.43 ng/mL
Standard Deviation 20.53
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 78, predose (n=10,8)
|
4.13 ng/mL
Standard Deviation 3.00
|
18.94 ng/mL
Standard Deviation 18.48
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 84, predose (n=11,5)
|
21.46 ng/mL
Standard Deviation 37.92
|
11.93 ng/mL
Standard Deviation 6.59
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 90, predose (n=10,5)
|
6.91 ng/mL
Standard Deviation 7.88
|
13.28 ng/mL
Standard Deviation 9.78
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 90, 0.5 hours postdose (n=0,1)
|
NA ng/mL
Standard Deviation NA
No participants were analyzed for the parameter at the specified timepoint.
|
17.70 ng/mL
Standard Deviation NA
No measure of dispersion could be determined as only 1 participant was analyzed.
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Month 96, predose (n=10,6)
|
21.07 ng/mL
Standard Deviation 39.16
|
31.97 ng/mL
Standard Deviation 24.39
|
—
|
|
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Follow-up, predose (n=1,1)
|
16.00 ng/mL
Standard Deviation NA
No measure of dispersion could be determined as only 1 participant was analyzed.
|
1.00 ng/mL
Standard Deviation NA
No measure of dispersion could be determined as only 1 participant was analyzed.
|
—
|
SECONDARY outcome
Timeframe: Months 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, and 72 and Follow-up (Month 98)Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
Outcome measures
| Measure |
Tacrolimus
n=16 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Trough Levels of Tacrolimus (ng/mL) by Visit
Month 72 (n=8)
|
7.13 ng/mL
Standard Deviation 1.64
|
—
|
—
|
|
Trough Levels of Tacrolimus (ng/mL) by Visit
Follow-up (n=1)
|
8.00 ng/mL
Standard Deviation NA
Measure of dispersion could not be calculated as only 1 participant was analyzed at this timepoint.
|
—
|
—
|
|
Trough Levels of Tacrolimus (ng/mL) by Visit
Month 9 (n=16)
|
7.00 ng/mL
Standard Deviation 1.55
|
—
|
—
|
|
Trough Levels of Tacrolimus (ng/mL) by Visit
Month 12 (n=10)
|
9.50 ng/mL
Standard Deviation 5.08
|
—
|
—
|
|
Trough Levels of Tacrolimus (ng/mL) by Visit
Month 18 (n=17)
|
8.00 ng/mL
Standard Deviation 2.81
|
—
|
—
|
|
Trough Levels of Tacrolimus (ng/mL) by Visit
Month 24 (n=9)
|
8.78 ng/mL
Standard Deviation 3.93
|
—
|
—
|
|
Trough Levels of Tacrolimus (ng/mL) by Visit
Month 30 (n=12)
|
6.17 ng/mL
Standard Deviation 2.55
|
—
|
—
|
|
Trough Levels of Tacrolimus (ng/mL) by Visit
Month 36 (n=15)
|
6.87 ng/mL
Standard Deviation 2.26
|
—
|
—
|
|
Trough Levels of Tacrolimus (ng/mL) by Visit
Month 42 (n=13)
|
7.08 ng/mL
Standard Deviation 1.85
|
—
|
—
|
|
Trough Levels of Tacrolimus (ng/mL) by Visit
Month 48 (n=15)
|
8.07 ng/mL
Standard Deviation 2.96
|
—
|
—
|
|
Trough Levels of Tacrolimus (ng/mL) by Visit
Month 54 (n=1)
|
10.00 ng/mL
Standard Deviation NA
Measure of dispersion could not be calculated as only 1 participant was analyzed at this timepoint.
|
—
|
—
|
|
Trough Levels of Tacrolimus (ng/mL) by Visit
Month 60 (n=12)
|
6.58 ng/mL
Standard Deviation 3.78
|
—
|
—
|
SECONDARY outcome
Timeframe: Months 12, 18, and 24Population: Safety population; n=number of participants in Safety Population per visit with non-missing value.
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 "how would you rate your health in general now?" (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Outcome measures
| Measure |
Tacrolimus
n=16 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=13 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=12 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale
PCS: Month 12 (n=12,13,9)
|
54.33 score on a scale
Standard Deviation 7.83
|
51.71 score on a scale
Standard Deviation 10.22
|
46.05 score on a scale
Standard Deviation 8.70
|
|
Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale
PCS: Month 18 (n=15,12,10)
|
53.76 score on a scale
Standard Deviation 8.18
|
50.67 score on a scale
Standard Deviation 10.48
|
46.89 score on a scale
Standard Deviation 9.61
|
|
Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale
PCS: Month 24 (n=16,13,12)
|
50.82 score on a scale
Standard Deviation 9.33
|
52.17 score on a scale
Standard Deviation 8.06
|
48.85 score on a scale
Standard Deviation 7.40
|
|
Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale
MCS: Month 12 (n=12,13,9)
|
53.39 score on a scale
Standard Deviation 7.93
|
50.83 score on a scale
Standard Deviation 11.12
|
54.08 score on a scale
Standard Deviation 10.32
|
|
Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale
MCS: Month 18 (n=15,12,10)
|
49.70 score on a scale
Standard Deviation 10.59
|
53.92 score on a scale
Standard Deviation 10.61
|
51.44 score on a scale
Standard Deviation 12.21
|
|
Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale
MCS: Month 24 (n=16,13,12)
|
50.70 score on a scale
Standard Deviation 9.40
|
55.61 score on a scale
Standard Deviation 6.00
|
52.14 score on a scale
Standard Deviation 8.89
|
SECONDARY outcome
Timeframe: Baseline, Months 12, 18, and 24Population: Safety population; n=number of participants in Safety population per visit with non-missing value.
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 "how would you rate your health in general now?" (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Negative change from baseline represented improvement.
Outcome measures
| Measure |
Tacrolimus
n=13 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=11 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=10 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale
PCS: Month 12 (n=12,11,9)
|
9.61 scores on a scale
Standard Deviation 6.21
|
6.23 scores on a scale
Standard Deviation 8.75
|
3.20 scores on a scale
Standard Deviation 10.71
|
|
Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale
PCS: Month 18 (n=13,9,8)
|
10.82 scores on a scale
Standard Deviation 6.29
|
5.65 scores on a scale
Standard Deviation 7.84
|
2.76 scores on a scale
Standard Deviation 10.26
|
|
Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale
PCS: Month 24 (n=13,10,10)
|
9.67 scores on a scale
Standard Deviation 5.55
|
7.09 scores on a scale
Standard Deviation 7.25
|
4.36 scores on a scale
Standard Deviation 8.60
|
|
Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale
MCS: Month 12 (n=12,11,9)
|
6.86 scores on a scale
Standard Deviation 7.35
|
5.03 scores on a scale
Standard Deviation 13.29
|
13.70 scores on a scale
Standard Deviation 12.32
|
|
Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale
MCS: Month 18 (n=13,9,8)
|
1.91 scores on a scale
Standard Deviation 14.71
|
9.54 scores on a scale
Standard Deviation 9.53
|
8.57 scores on a scale
Standard Deviation 13.96
|
|
Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale
MCS: Month 24 (n=13,10,10)
|
2.99 scores on a scale
Standard Deviation 11.63
|
10.05 scores on a scale
Standard Deviation 12.55
|
9.59 scores on a scale
Standard Deviation 15.22
|
SECONDARY outcome
Timeframe: Months 12, 18, and 24Population: Safety population; n=number of participants in Safety Population per visit with non-missing value.
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 "how would you rate your health in general now?" (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Outcome measures
| Measure |
Tacrolimus
n=16 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=13 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=12 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
SF-36 v2 Subscale Scores by Visit
Vitality: Month 12 (n=13,13,9)
|
59.78 scores on a scale
Standard Deviation 5.67
|
55.64 scores on a scale
Standard Deviation 13.28
|
58.61 scores on a scale
Standard Deviation 11.86
|
|
SF-36 v2 Subscale Scores by Visit
TR Scale Score: Month 18 (n=15,12,10)
|
1.53 scores on a scale
Standard Deviation 0.74
|
1.67 scores on a scale
Standard Deviation 0.78
|
1.70 scores on a scale
Standard Deviation 1.06
|
|
SF-36 v2 Subscale Scores by Visit
Phys Func: Month 12 (n=13,13,9)
|
53.49 scores on a scale
Standard Deviation 8.32
|
47.82 scores on a scale
Standard Deviation 14.75
|
47.56 scores on a scale
Standard Deviation 10.97
|
|
SF-36 v2 Subscale Scores by Visit
Phys Func: Month 18 (n=15,12,10)
|
53.16 scores on a scale
Standard Deviation 7.68
|
50.29 scores on a scale
Standard Deviation 11.22
|
44.42 scores on a scale
Standard Deviation 11.12
|
|
SF-36 v2 Subscale Scores by Visit
Phys Func: Month 24 (n=16,13,12)
|
50.84 scores on a scale
Standard Deviation 9.44
|
52.70 scores on a scale
Standard Deviation 8.47
|
47.39 scores on a scale
Standard Deviation 9.28
|
|
SF-36 v2 Subscale Scores by Visit
Physical: Month 12 (n=13,13,9)
|
49.65 scores on a scale
Standard Deviation 11.30
|
51.85 scores on a scale
Standard Deviation 10.67
|
42.57 scores on a scale
Standard Deviation 13.20
|
|
SF-36 v2 Subscale Scores by Visit
Physical: Month 18 (n=15,12,10)
|
52.01 scores on a scale
Standard Deviation 8.19
|
50.26 scores on a scale
Standard Deviation 8.89
|
46.12 scores on a scale
Standard Deviation 11.37
|
|
SF-36 v2 Subscale Scores by Visit
Physical: Month 24 (n=16,13,12)
|
48.12 scores on a scale
Standard Deviation 14.60
|
53.69 scores on a scale
Standard Deviation 6.69
|
51.45 scores on a scale
Standard Deviation 6.42
|
|
SF-36 v2 Subscale Scores by Visit
Bodily Pain: Month 12 (n=13,13,9)
|
53.19 scores on a scale
Standard Deviation 13.05
|
54.25 scores on a scale
Standard Deviation 7.34
|
50.70 scores on a scale
Standard Deviation 11.18
|
|
SF-36 v2 Subscale Scores by Visit
Bodily Pain: Month 18 (n=15,12,10)
|
53.53 scores on a scale
Standard Deviation 9.59
|
54.32 scores on a scale
Standard Deviation 11.78
|
52.64 scores on a scale
Standard Deviation 10.01
|
|
SF-36 v2 Subscale Scores by Visit
Bodily Pain: Month 24 (n=16,13,12)
|
53.02 scores on a scale
Standard Deviation 9.20
|
50.57 scores on a scale
Standard Deviation 12.55
|
51.51 scores on a scale
Standard Deviation 8.78
|
|
SF-36 v2 Subscale Scores by Visit
General Health: Month 12 (n=12,13,9)
|
57.18 scores on a scale
Standard Deviation 6.12
|
52.96 scores on a scale
Standard Deviation 8.50
|
47.86 scores on a scale
Standard Deviation 8.52
|
|
SF-36 v2 Subscale Scores by Visit
General Health: Month 18 (n=15,12,10)
|
52.54 scores on a scale
Standard Deviation 10.64
|
50.10 scores on a scale
Standard Deviation 8.89
|
46.67 scores on a scale
Standard Deviation 10.08
|
|
SF-36 v2 Subscale Scores by Visit
General Health: Month 24 (n=16,13,12)
|
49.54 scores on a scale
Standard Deviation 10.37
|
54.33 scores on a scale
Standard Deviation 8.23
|
48.14 scores on a scale
Standard Deviation 6.20
|
|
SF-36 v2 Subscale Scores by Visit
Vitality: Month 18 (n=15,12,10)
|
53.55 scores on a scale
Standard Deviation 10.11
|
57.44 scores on a scale
Standard Deviation 11.69
|
53.75 scores on a scale
Standard Deviation 10.58
|
|
SF-36 v2 Subscale Scores by Visit
Vitality: Month 24 (n=16,13,12)
|
54.14 scores on a scale
Standard Deviation 10.88
|
59.55 scores on a scale
Standard Deviation 7.19
|
50.96 scores on a scale
Standard Deviation 9.75
|
|
SF-36 v2 Subscale Scores by Visit
Social Function: Month 12 (n=13,13,9)
|
48.96 scores on a scale
Standard Deviation 8.37
|
46.48 scores on a scale
Standard Deviation 13.14
|
50.43 scores on a scale
Standard Deviation 9.10
|
|
SF-36 v2 Subscale Scores by Visit
Social Function: Month 18 (n=15,12,10)
|
49.59 scores on a scale
Standard Deviation 9.85
|
50.58 scores on a scale
Standard Deviation 10.11
|
50.49 scores on a scale
Standard Deviation 12.53
|
|
SF-36 v2 Subscale Scores by Visit
Social Function: Month 24 (n=16,13,12)
|
51.36 scores on a scale
Standard Deviation 7.72
|
52.27 scores on a scale
Standard Deviation 7.00
|
51.03 scores on a scale
Standard Deviation 9.17
|
|
SF-36 v2 Subscale Scores by Visit
Emotional: Month 12 (n=13,13,9)
|
49.27 scores on a scale
Standard Deviation 13.51
|
49.56 scores on a scale
Standard Deviation 10.54
|
48.53 scores on a scale
Standard Deviation 10.61
|
|
SF-36 v2 Subscale Scores by Visit
Emotional: Month 18 (n=15,12,10)
|
51.64 scores on a scale
Standard Deviation 8.87
|
50.63 scores on a scale
Standard Deviation 10.12
|
48.49 scores on a scale
Standard Deviation 12.42
|
|
SF-36 v2 Subscale Scores by Visit
Emotional: Month 24 (n=16,13,12)
|
47.63 scores on a scale
Standard Deviation 14.49
|
52.18 scores on a scale
Standard Deviation 7.16
|
52.52 scores on a scale
Standard Deviation 4.52
|
|
SF-36 v2 Subscale Scores by Visit
Mental Health: Month 12 (n=13,13,9)
|
54.05 scores on a scale
Standard Deviation 8.04
|
51.71 scores on a scale
Standard Deviation 9.67
|
52.35 scores on a scale
Standard Deviation 9.08
|
|
SF-36 v2 Subscale Scores by Visit
Mental Health: Month 18 (n=15,12,10)
|
49.21 scores on a scale
Standard Deviation 11.37
|
54.66 scores on a scale
Standard Deviation 9.87
|
49.02 scores on a scale
Standard Deviation 11.37
|
|
SF-36 v2 Subscale Scores by Visit
Mental Health: Month 24 (n=16,13,12)
|
51.31 scores on a scale
Standard Deviation 8.58
|
56.19 scores on a scale
Standard Deviation 6.45
|
50.50 scores on a scale
Standard Deviation 9.84
|
|
SF-36 v2 Subscale Scores by Visit
TR Scale Score: Month 12 (n=13,13,9)
|
1.23 scores on a scale
Standard Deviation 0.83
|
1.23 scores on a scale
Standard Deviation 0.83
|
1.33 scores on a scale
Standard Deviation 1.00
|
|
SF-36 v2 Subscale Scores by Visit
TR Scale Score: Month 24 (n=16,13,12)
|
2.00 scores on a scale
Standard Deviation 0.97
|
1.62 scores on a scale
Standard Deviation 0.77
|
2.33 scores on a scale
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: Baseline, Months 12, 18, and 24Population: Safety population; n=number of participants in Safety Population per visit with non-missing value.
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 "how would you rate your health in general now?" (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Negative change from baseline represented improvement.
Outcome measures
| Measure |
Tacrolimus
n=13 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=12 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=10 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
Mental Health: Month 12 (n=13,12,9)
|
2.98 scores on a scale
Standard Deviation 6.64
|
4.62 scores on a scale
Standard Deviation 8.71
|
5.54 scores on a scale
Standard Deviation 13.64
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
Phys Func: Month 12 (n=13,12,9)
|
8.82 scores on a scale
Standard Deviation 10.58
|
0.51 scores on a scale
Standard Deviation 12.47
|
5.23 scores on a scale
Standard Deviation 14.94
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
Phys Func: Month 18 (n=13,10,8)
|
9.90 scores on a scale
Standard Deviation 10.46
|
4.50 scores on a scale
Standard Deviation 9.92
|
2.56 scores on a scale
Standard Deviation 15.58
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
Phys Func: Month 24 (n=13,11,10)
|
8.48 scores on a scale
Standard Deviation 10.27
|
3.91 scores on a scale
Standard Deviation 7.12
|
4.30 scores on a scale
Standard Deviation 9.86
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
Physical: Month 12 (n=13,12,9)
|
13.77 scores on a scale
Standard Deviation 8.16
|
12.92 scores on a scale
Standard Deviation 14.51
|
11.67 scores on a scale
Standard Deviation 14.14
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
Physical: Month 18 (n=13,10,8)
|
15.60 scores on a scale
Standard Deviation 6.36
|
9.54 scores on a scale
Standard Deviation 9.68
|
12.53 scores on a scale
Standard Deviation 9.44
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
Physical: Month 24 (n=13,11,10)
|
12.30 scores on a scale
Standard Deviation 8.76
|
13.23 scores on a scale
Standard Deviation 13.13
|
17.18 scores on a scale
Standard Deviation 13.81
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
Bodily Pain: Month 12 (n=13,12,9)
|
1.47 scores on a scale
Standard Deviation 15.91
|
6.87 scores on a scale
Standard Deviation 10.52
|
-0.83 scores on a scale
Standard Deviation 14.54
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
Bodily Pain: Month 18 (n=13,10,8)
|
0.83 scores on a scale
Standard Deviation 11.32
|
8.08 scores on a scale
Standard Deviation 12.98
|
-0.31 scores on a scale
Standard Deviation 14.06
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
Bodily Pain: Month 24 (n=13,11,10)
|
2.56 scores on a scale
Standard Deviation 10.01
|
5.57 scores on a scale
Standard Deviation 12.58
|
-1.25 scores on a scale
Standard Deviation 12.99
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
General Health: Month 12 (n=12,11,9)
|
11.73 scores on a scale
Standard Deviation 5.80
|
6.75 scores on a scale
Standard Deviation 12.04
|
3.60 scores on a scale
Standard Deviation 7.67
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
General Health: Month 18 (n=13,9,8)
|
8.89 scores on a scale
Standard Deviation 9.64
|
6.94 scores on a scale
Standard Deviation 8.80
|
-1.29 scores on a scale
Standard Deviation 11.83
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
General Health: Month 24 (n=13,10,10)
|
8.06 scores on a scale
Standard Deviation 8.96
|
9.11 scores on a scale
Standard Deviation 7.86
|
1.83 scores on a scale
Standard Deviation 8.55
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
Vitality: Month 12 (n=13,12,9)
|
11.05 scores on a scale
Standard Deviation 9.58
|
9.23 scores on a scale
Standard Deviation 15.29
|
16.30 scores on a scale
Standard Deviation 8.87
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
Vitality: Month 18 (n=13,10,8)
|
7.14 scores on a scale
Standard Deviation 13.36
|
11.67 scores on a scale
Standard Deviation 13.49
|
10.85 scores on a scale
Standard Deviation 6.96
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
Vitality: Month 24 (n=13,11,8)
|
8.90 scores on a scale
Standard Deviation 10.52
|
15.51 scores on a scale
Standard Deviation 11.96
|
7.18 scores on a scale
Standard Deviation 14.06
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
Social Function: Month 12 (n=13,12,9)
|
4.14 scores on a scale
Standard Deviation 10.79
|
7.62 scores on a scale
Standard Deviation 14.76
|
11.95 scores on a scale
Standard Deviation 12.55
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
Social Function: Month 18 (n=13,10,8)
|
4.55 scores on a scale
Standard Deviation 14.54
|
11.83 scores on a scale
Standard Deviation 11.84
|
8.74 scores on a scale
Standard Deviation 13.77
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
Social Function: Month 24 (n=13,11,10)
|
7.03 scores on a scale
Standard Deviation 12.68
|
11.73 scores on a scale
Standard Deviation 11.49
|
9.68 scores on a scale
Standard Deviation 15.38
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
Emotional: Month 12 (n=13,12,9)
|
10.19 scores on a scale
Standard Deviation 13.06
|
7.26 scores on a scale
Standard Deviation 19.87
|
15.14 scores on a scale
Standard Deviation 17.45
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
Emotional: Month 18 (n=13,10,8)
|
9.32 scores on a scale
Standard Deviation 15.35
|
11.74 scores on a scale
Standard Deviation 17.25
|
13.25 scores on a scale
Standard Deviation 16.56
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
Emotional: Month 24 (n=13,11,10)
|
4.66 scores on a scale
Standard Deviation 17.15
|
6.54 scores on a scale
Standard Deviation 15.25
|
16.66 scores on a scale
Standard Deviation 18.82
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
Mental Health: Month 18 (n=13,10,8)
|
-1.28 scores on a scale
Standard Deviation 13.51
|
8.03 scores on a scale
Standard Deviation 5.76
|
0.00 scores on a scale
Standard Deviation 14.36
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
Mental Health: Month 24 (n=13,11,10)
|
1.70 scores on a scale
Standard Deviation 9.36
|
10.58 scores on a scale
Standard Deviation 10.20
|
2.22 scores on a scale
Standard Deviation 12.72
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
TR Scale Score: Month 12 (n=13,12,9)
|
-1.31 scores on a scale
Standard Deviation 1.55
|
-1.83 scores on a scale
Standard Deviation 1.40
|
-1.78 scores on a scale
Standard Deviation 2.11
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
TR Scale Score: Month 18 (n=13,10,8)
|
-1.15 scores on a scale
Standard Deviation 1.28
|
-1.10 scores on a scale
Standard Deviation 1.37
|
-1.13 scores on a scale
Standard Deviation 1.81
|
|
Change From Baseline in SF-36 v2 Subscale Scores by Visit
TR Scale Score: Month 24 (n=13,11,10)
|
-0.92 scores on a scale
Standard Deviation 1.19
|
-1.45 scores on a scale
Standard Deviation 1.21
|
-0.70 scores on a scale
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: Months 12, 18, and 24Population: Safety population; n=number of participants in Safety Population per visit with non-missing value.
ESRD-SCL: 43-item, disease-specific, self-administered questionnaire. Participants' rated question "At the moment, how much do you suffer?" for each item on 5-point scale, ranged from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: cardiac and renal dysfunction (Range, 0-28), increased growth of gum and hair (Range, 0-20), limited cognitive capacity (Range, 0-32), limited physical capacity (Range, 0-40), side effects (SEs) of corticosteroids (Range, 0-20), transplantation associated psychological distress (TAPD; Range, 0-32); higher scores=greater dysfunction for each subscale. Total score: 0-172, higher scores=greater dysfunction.
Outcome measures
| Measure |
Tacrolimus
n=16 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=13 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=11 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
Limited Physical: Month 18 (n = 15, 12, 10)
|
0.53 scores on a scale
Standard Deviation 0.69
|
0.41 scores on a scale
Standard Deviation 0.38
|
0.46 scores on a scale
Standard Deviation 0.55
|
|
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
Limited Cognitive: Month 24 (n = 16, 13, 11)
|
0.65 scores on a scale
Standard Deviation 0.85
|
0.57 scores on a scale
Standard Deviation 0.67
|
0.48 scores on a scale
Standard Deviation 0.54
|
|
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
Cardiac / Renal Dysfunc: Month 12 (n = 13, 13, 8)
|
0.18 scores on a scale
Standard Deviation 0.26
|
0.27 scores on a scale
Standard Deviation 0.31
|
0.18 scores on a scale
Standard Deviation 0.18
|
|
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
Side effects Corticosteroids: Month24 (n=15,13,11)
|
0.53 scores on a scale
Standard Deviation 0.64
|
0.26 scores on a scale
Standard Deviation 0.35
|
0.69 scores on a scale
Standard Deviation 0.66
|
|
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
Increased growth gum/hair: Month 12 (n=13,13,4)
|
0.17 scores on a scale
Standard Deviation 0.24
|
0.15 scores on a scale
Standard Deviation 0.25
|
0.08 scores on a scale
Standard Deviation 0.15
|
|
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
Cardiac / Renal Dysfunc: Month 18 (n = 14, 12, 9)
|
0.25 scores on a scale
Standard Deviation 0.38
|
0.30 scores on a scale
Standard Deviation 0.31
|
0.22 scores on a scale
Standard Deviation 0.20
|
|
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
Cardiac / Renal Dysfunc: Month 24 (n = 15, 13, 11)
|
0.33 scores on a scale
Standard Deviation 0.51
|
0.31 scores on a scale
Standard Deviation 0.35
|
0.34 scores on a scale
Standard Deviation 0.24
|
|
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
Side effects Corticosteroids: Month 12 (n=13,13,8)
|
0.29 scores on a scale
Standard Deviation 0.35
|
0.57 scores on a scale
Standard Deviation 0.80
|
0.70 scores on a scale
Standard Deviation 0.83
|
|
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
Side effects Corticosteroids: Month18 (n=14,12,10)
|
0.39 scores on a scale
Standard Deviation 0.65
|
0.45 scores on a scale
Standard Deviation 0.66
|
0.58 scores on a scale
Standard Deviation 0.61
|
|
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
Increased growth gum/hair: Month 18 (n=15,12,10)
|
0.17 scores on a scale
Standard Deviation 0.28
|
0.23 scores on a scale
Standard Deviation 0.31
|
0.14 scores on a scale
Standard Deviation 0.16
|
|
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
Increased growth gum/hair: Month 24 (n=16,13,11)
|
0.41 scores on a scale
Standard Deviation 0.49
|
0.28 scores on a scale
Standard Deviation 0.48
|
0.11 scores on a scale
Standard Deviation 0.21
|
|
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
Transplant-assoc psycho distress:Mnth12(n=13,12,8)
|
0.40 scores on a scale
Standard Deviation 0.42
|
0.50 scores on a scale
Standard Deviation 0.41
|
0.48 scores on a scale
Standard Deviation 0.33
|
|
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
Transplant-assoc psychodistress:Mnth18(n=15,12,10)
|
0.70 scores on a scale
Standard Deviation 0.81
|
0.42 scores on a scale
Standard Deviation 0.37
|
0.47 scores on a scale
Standard Deviation 0.19
|
|
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
Transplant-assoc psychodistress:Mnth24(n=16,13,11)
|
0.77 scores on a scale
Standard Deviation 0.72
|
0.45 scores on a scale
Standard Deviation 0.40
|
0.57 scores on a scale
Standard Deviation 0.74
|
|
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
Global Score: Month 12 (n = 13, 12, 8)
|
0.28 scores on a scale
Standard Deviation 0.26
|
0.39 scores on a scale
Standard Deviation 0.36
|
0.33 scores on a scale
Standard Deviation 0.25
|
|
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
Global Score: Month 18 (n = 15, 12, 10)
|
0.50 scores on a scale
Standard Deviation 0.65
|
0.38 scores on a scale
Standard Deviation 0.34
|
0.36 scores on a scale
Standard Deviation 0.25
|
|
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
Global Score: Month 24 (n = 16, 13, 11)
|
0.57 scores on a scale
Standard Deviation 0.59
|
0.40 scores on a scale
Standard Deviation 0.40
|
0.47 scores on a scale
Standard Deviation 0.41
|
|
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
Limited Physical: Month 12 (n = 13, 12, 8)
|
0.22 scores on a scale
Standard Deviation 0.25
|
0.37 scores on a scale
Standard Deviation 0.40
|
0.29 scores on a scale
Standard Deviation 0.40
|
|
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
Limited Physical: Month 24 (n = 16, 13, 11)
|
0.60 scores on a scale
Standard Deviation 0.69
|
0.44 scores on a scale
Standard Deviation 0.46
|
0.55 scores on a scale
Standard Deviation 0.46
|
|
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
Limited Cognitive: Month 12 (n = 13, 12, 8)
|
0.41 scores on a scale
Standard Deviation 0.40
|
0.45 scores on a scale
Standard Deviation 0.45
|
0.30 scores on a scale
Standard Deviation 0.36
|
|
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
Limited Cognitive: Month 18 (n = 15, 12, 10)
|
0.63 scores on a scale
Standard Deviation 0.89
|
0.42 scores on a scale
Standard Deviation 0.42
|
0.29 scores on a scale
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Baseline, Months 12, 18, and 24Population: Safety population; n=number of participants in Safety Population per visit with non-missing value.
ESRD-SCL: 43-item, disease-specific, self-administered questionnaire. Participants' rated question "At the moment, how much do you suffer?" for each item on 5-point scale, ranged from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: cardiac and renal dysfunction (Range, 0-28), increased growth of gum and hair (Range, 0-20), limited cognitive capacity (Range, 0-32), limited physical capacity (Range, 0-40), SEs of corticosteroids (Range, 0-20),TAPD (Range, 0-32); higher scores=greater dysfunction for each subscale. Total score: 0-172, higher scores=greater dysfunction.
Outcome measures
| Measure |
Tacrolimus
n=13 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=10 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=9 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
Limited Physical: Month 24 (n = 13, 10, 9)
|
-0.16 scores on a scale
Standard Deviation 0.63
|
-0.23 scores on a scale
Standard Deviation 0.28
|
-0.32 scores on a scale
Standard Deviation 0.39
|
|
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
Limited Cognitive: Month 18 (n = 13, 9, 8)
|
-0.22 scores on a scale
Standard Deviation 0.80
|
-0.39 scores on a scale
Standard Deviation 0.45
|
-0.39 scores on a scale
Standard Deviation 0.54
|
|
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
Side effects Corticosteroids: Month 24 (n=13,10,9)
|
-0.25 scores on a scale
Standard Deviation 0.68
|
-0.31 scores on a scale
Standard Deviation 0.55
|
0.13 scores on a scale
Standard Deviation 0.53
|
|
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
Limited Physical: Month 12 (n = 13, 10, 8)
|
-0.34 scores on a scale
Standard Deviation 0.45
|
-0.34 scores on a scale
Standard Deviation 0.25
|
-0.53 scores on a scale
Standard Deviation 0.38
|
|
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
Limited Physical: Month 18 (n = 13, 9, 8)
|
-0.20 scores on a scale
Standard Deviation 0.54
|
-0.36 scores on a scale
Standard Deviation 0.32
|
-0.30 scores on a scale
Standard Deviation 0.63
|
|
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
Limited Cognitive: Month 12 (n = 13, 10, 8)
|
-0.37 scores on a scale
Standard Deviation 0.59
|
-0.37 scores on a scale
Standard Deviation 0.24
|
-0.36 scores on a scale
Standard Deviation 0.65
|
|
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
Limited Cognitive: Month 24 (n = 13, 10, 9)
|
-0.25 scores on a scale
Standard Deviation 0.89
|
-0.21 scores on a scale
Standard Deviation 0.56
|
-0.26 scores on a scale
Standard Deviation 0.72
|
|
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
Cardiac / Renal Dysfunc: Month 12 (n = 13, 9, 8)
|
-0.48 scores on a scale
Standard Deviation 0.68
|
-0.51 scores on a scale
Standard Deviation 0.43
|
-0.52 scores on a scale
Standard Deviation 0.49
|
|
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
Cardiac / Renal Dysfunc: Month 18 (n = 12, 8, 7)
|
-0.49 scores on a scale
Standard Deviation 0.78
|
-0.50 scores on a scale
Standard Deviation 0.41
|
-0.45 scores on a scale
Standard Deviation 0.60
|
|
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
Cardiac / Renal Dysfunc: Month 24 (n = 13, 9, 9)
|
-0.46 scores on a scale
Standard Deviation 0.61
|
-0.41 scores on a scale
Standard Deviation 0.39
|
-0.33 scores on a scale
Standard Deviation 0.44
|
|
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
Side effects Corticosteroids: Month 12(n=13, 9, 8)
|
-0.25 scores on a scale
Standard Deviation 0.55
|
-0.02 scores on a scale
Standard Deviation 0.66
|
0.18 scores on a scale
Standard Deviation 0.61
|
|
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
Side effects Corticosteroids: Month 18 (n=12,8,8)
|
-0.40 scores on a scale
Standard Deviation 0.72
|
-0.23 scores on a scale
Standard Deviation 0.43
|
0.03 scores on a scale
Standard Deviation 0.52
|
|
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
Increased growth gum/hair: Month 12 (n=13,10,8)
|
0.06 scores on a scale
Standard Deviation 0.28
|
-0.06 scores on a scale
Standard Deviation 0.40
|
-0.08 scores on a scale
Standard Deviation 0.24
|
|
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
Increased growth gum/hair: Month 18 (n=13,9,8)
|
0.04 scores on a scale
Standard Deviation 0.27
|
-0.04 scores on a scale
Standard Deviation 0.46
|
-0.03 scores on a scale
Standard Deviation 0.23
|
|
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
Increased growth gum/hair: Month 24 (n=13,10,9)
|
0.29 scores on a scale
Standard Deviation 0.59
|
0.10 scores on a scale
Standard Deviation 0.63
|
-0.07 scores on a scale
Standard Deviation 0.17
|
|
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
Transplant-assoc psychodistress: Mnth12(n=13,10,8)
|
-0.49 scores on a scale
Standard Deviation 0.56
|
-0.57 scores on a scale
Standard Deviation 0.58
|
-0.61 scores on a scale
Standard Deviation 0.42
|
|
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
Transplant-assoc psychodistress: Mnth18(n=13,9,8)
|
-0.28 scores on a scale
Standard Deviation 0.46
|
-0.57 scores on a scale
Standard Deviation 0.55
|
-0.48 scores on a scale
Standard Deviation 0.58
|
|
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
Transplant-assoc psychodistress: Mnth24(n=13,10,9)
|
-0.30 scores on a scale
Standard Deviation 0.51
|
-0.62 scores on a scale
Standard Deviation 0.67
|
-0.61 scores on a scale
Standard Deviation 0.70
|
|
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
Global Score: Month 12 (n = 13, 10, 8)
|
-0.34 scores on a scale
Standard Deviation 0.37
|
-0.36 scores on a scale
Standard Deviation 0.24
|
-0.37 scores on a scale
Standard Deviation 0.29
|
|
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
Global Score: Month 18 (n = 13, 9, 8)
|
-0.21 scores on a scale
Standard Deviation 0.57
|
-0.40 scores on a scale
Standard Deviation 0.31
|
-0.31 scores on a scale
Standard Deviation 0.36
|
|
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
Global Score: Month 24 (n = 13, 10, 9)
|
-0.21 scores on a scale
Standard Deviation 0.52
|
-0.30 scores on a scale
Standard Deviation 0.31
|
-0.28 scores on a scale
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Months 12, 18, and 24Population: Safety population; n=number of participants in Safety Population per visit with non-missing value.
HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any number of events including visits to doctor or other healthcare professionals (HCP), non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Outcome measures
| Measure |
Tacrolimus
n=12 Participants
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=11 Participants
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=9 Participants
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire
Other Test/Procedures: Month 18 (n=4,3,0)
|
2.5 events
Standard Deviation 1.7
|
2.0 events
Standard Deviation 1.7
|
NA events
Standard Deviation NA
No participants were analyzed for this parameter in this treatment group at this timepoint.
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire
Doctor/HCP Visits: Month 12 (n=9,10,4)
|
3.1 events
Standard Deviation 3.1
|
2.7 events
Standard Deviation 2.5
|
6.3 events
Standard Deviation 3.9
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire
Doctor/HCP Visits: Month 18 (n=10,9,6)
|
7.2 events
Standard Deviation 9.0
|
6.4 events
Standard Deviation 7.5
|
5.8 events
Standard Deviation 2.7
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire
Doctor/HCP Visits: Month 24 (n=12,11,9)
|
5.1 events
Standard Deviation 4.2
|
2.5 events
Standard Deviation 2.0
|
5.0 events
Standard Deviation 6.3
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire
Other Test/Procedures: Month 12 (n=1,4,4)
|
1.0 events
Standard Deviation NA
Measure of dispersion could not be calculated as only 1 participant was analyzed at this timepoint.
|
2.0 events
Standard Deviation 1.4
|
2.3 events
Standard Deviation 1.9
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire
Other Test/Procedures: Month 24 (n=4,3,4)
|
3.8 events
Standard Deviation 2.8
|
1.3 events
Standard Deviation 0.6
|
2.8 events
Standard Deviation 2.2
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire
Previous Hospitalizations: Month 12 (n=1,1,2)
|
2.0 events
Standard Deviation NA
Measure of dispersion could not be calculated as only 1 participant was analyzed at this timepoint.
|
1.0 events
Standard Deviation NA
Measure of dispersion could not be calculated as only 1 participant was analyzed at this timepoint.
|
1.0 events
Standard Deviation 0.0
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire
Previous Hospitalizations: Month 18 (n=3,1,1)
|
1.3 events
Standard Deviation 0.6
|
1.0 events
Standard Deviation NA
Measure of dispersion could not be calculated as only 1 participant was analyzed at this timepoint.
|
2.0 events
Standard Deviation NA
Measure of dispersion could not be calculated as only 1 participant was analyzed at this timepoint.
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire
Previous Hospitalizations: Month 24 (n=3,3,1)
|
1.0 events
Standard Deviation 0.0
|
1.0 events
Standard Deviation 0.0
|
1.0 events
Standard Deviation NA
Measure of dispersion could not be calculated as only 1 participant was analyzed at this timepoint.
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire
Emergency Room Visits: Month 12 (n=1,1,2)
|
1.0 events
Standard Deviation NA
Measure of dispersion could not be calculated as only 1 participant was analyzed at this timepoint.
|
1.0 events
Standard Deviation NA
Measure of dispersion could not be calculated as only 1 participant was analyzed at this timepoint.
|
1.0 events
Standard Deviation 0.0
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire
Emergency Room Visits: Month 18 (n=3,3,1)
|
1.3 events
Standard Deviation 0.6
|
1.0 events
Standard Deviation 0.0
|
2.0 events
Standard Deviation NA
Measure of dispersion could not be calculated as only 1 participant was analyzed at this timepoint.
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire
Emergency Room Visits: Month 24 (n=4,2,2)
|
1.0 events
Standard Deviation 0.0
|
1.0 events
Standard Deviation 0.0
|
1.0 events
Standard Deviation 0.0
|
Adverse Events
Tacrolimus
Serious events: 7 serious events
Other events: 17 other events
Deaths: 0 deaths
Tofacitinib 15-10-5 mg BID
Serious events: 10 serious events
Other events: 14 other events
Deaths: 0 deaths
Tofacitinib 30-15-10 mg BID
Serious events: 8 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tacrolimus
n=18 participants at risk
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 participants at risk
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=13 participants at risk
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Transplant rejection
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.3%
2/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gangrene
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Histoplasmosis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Mastitis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pyelonephritis
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Renal cyst infection
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Septic shock
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.3%
2/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatinine increased
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Transaminases increased
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the appendix
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma metastatic
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Syncope
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure acute
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Tacrolimus
n=18 participants at risk
Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 15-10-5 mg BID
n=14 participants at risk
Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
Tofacitinib 30-15-10 mg BID
n=13 participants at risk
Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.3%
2/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
3/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
3/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac flutter
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Hypertensive heart disease
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
28.6%
4/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Sinus tachycardia
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Ear discomfort
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Ear disorder
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Ear pain
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Hypoacusis
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Blepharitis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Cataract
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye swelling
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Glaucoma
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Hyphaema
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Vision blurred
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Visual acuity reduced
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Visual impairment
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.3%
2/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.3%
2/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
55.6%
10/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
35.7%
5/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
23.1%
3/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gingival hypertrophy
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.3%
2/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
21.4%
3/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Asthenia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
22.2%
4/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.3%
2/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
30.8%
4/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Gravitational oedema
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Local swelling
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
35.7%
5/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
23.1%
3/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pain
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.3%
2/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Sluggishness
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Seasonal allergy
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Transplant rejection
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
BK virus infection
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.3%
2/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.3%
2/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Chronic sinusitis
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cystitis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cytomegalovirus infection
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Ear infection
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Folliculitis
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Fungal infection
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis viral
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes zoster
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
35.7%
5/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Incision site abscess
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Infected cyst
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Localised infection
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oral candidiasis
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
21.4%
3/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Papilloma viral infection
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pyelonephritis
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.3%
2/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Skin candida
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tinea versicolour
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
35.7%
5/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
38.5%
5/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
3/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
35.7%
5/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Chloracne
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Complications of transplant surgery
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Repetitive strain injury
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.3%
2/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Arterial bruit
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
23.1%
3/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood calcium decreased
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatinine increased
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood culture positive
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood glucose increased
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood potassium decreased
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood pressure increased
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Cardiac murmur
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.3%
2/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Culture urine positive
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Electrocardiogram P wave abnormal
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
QRS axis abnormal
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Viral test positive
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Vitamin D decreased
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight decreased
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
21.4%
3/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight increased
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
30.8%
4/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
16.7%
3/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Magnesium deficiency
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
30.8%
4/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
23.1%
3/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bone metabolism disorder
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
3/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.3%
2/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
30.8%
4/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.3%
2/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen’s disease
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer stage 0
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.3%
2/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.3%
2/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
30.8%
4/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Migraine
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Tarsal tunnel syndrome
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Tremor
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.3%
2/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Confusional state
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
28.6%
4/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
23.1%
3/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
21.4%
3/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Kidney fibrosis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Nocturia
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal cyst
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal hypertrophy
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Nipple exudate bloody
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
4/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
28.6%
4/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
23.1%
3/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
23.1%
3/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.3%
2/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
23.1%
3/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
2/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.3%
2/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Itching scar
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
28.6%
4/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.3%
2/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Raynaud’s phenomenon
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Thrombosed varicose vein
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/18 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • Adverse events (AEs; serious and nonserious) were recorded from the time the participant had taken at least 1 dose of trial treatment through the follow-up visit at Month 98 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER