Trial Outcomes & Findings for Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA) (NCT NCT00254293)
NCT ID: NCT00254293
Last Updated: 2014-04-08
Results Overview
Participants received abatacept while also receiving DMARDS over a short term (ST) 12 Week period. To eliminate contribution from the IV loading dose of abatacept during the short term study period, Cmin values were selected from Days 71 to 85, when contribution from IV was negligible. Minimum trough serum concentration of abatacept (Cmin) was measured in micrograms/milliliter (µg/mL). Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
87 participants
Primary outcome timeframe
Days 71 to 85
Results posted on
2014-04-08
Participant Flow
Short term (12 week) randomized Period: started January 2006/completed May 2007. Long term extension (LTE): started April 2006/completed July 2012. During LTE: variable dose period and fixed dose period. Patients with active Rheumatoid Arthritis (RA) and receiving disease modifying anti-rheumatic drugs (DMARDS) were eligible to participate.
Enrolled/not treated (19): prior treatment not washed out; no longer met study criteria; withdrew consent before treatment. To enter LTE, participant completed the short term period, and was assigned to a variable SC dose group (75, 125, 200 mg SC abatacept) based on body weight; completers of variable dose LTE rolled over into fixed dose LTE.
Participant milestones
| Measure |
Group 1: 500 mg IV/75 mg SC
Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); body weight \< 60 kg. Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period) on Day 85 (IV abatacept based on their weight at screening; \< 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, \> 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
|
Group 2: 500 mg IV/125 mg SC
Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo;body weight \< 60 kg. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period; loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Variable Long term for 125 mg SC: body weight \<60 to \>100 kg. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
|
Group 3 : 750 mg IV/125 mg SC
Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo (body weight 60-100 kg). Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Variable Long term for 125 mg SC: body weight \<60 to \>100 kg). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
|
Group 4: 1000mg IV/125 mg SC
Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo; Body weight \> 100 kg. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period); variable long term for 125 mg SC: body weight \<60 to \>100 kg) . Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
|
Group 5: 1000 mg IV/200 mg SC
Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo; body weight \> 100 kg. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose based on weight as described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
|
Placebo
Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), by body weight. Long term extension (LTE) variable dosing period: all placebo participants rolled over to a variable dose of abatacept SC (75, 125, 200 mg) administered weekly following an IV loading dose of abatacept on Day 85. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
|
Fixed Dose 125 mg Abatacept
Participants who completed the variable dose long term extension (LTE)period and received variable doses of subcutaneous (SC) abatacept (75, 125, 200 mg SC) were rolled over into the LTE with fixed dose, irrespective of body weight: SC abatacept 125 milligram (mg) in pre-filled syringes, administered Weekly.
|
|---|---|---|---|---|---|---|---|
|
Short Term (12 Week) Randomized Dosing
STARTED
|
7
|
4
|
29
|
6
|
5
|
17
|
0
|
|
Short Term (12 Week) Randomized Dosing
COMPLETED
|
7
|
3
|
26
|
5
|
5
|
17
|
0
|
|
Short Term (12 Week) Randomized Dosing
NOT COMPLETED
|
0
|
1
|
3
|
1
|
0
|
0
|
0
|
|
LTE Open Label Variable SC Dosing
STARTED
|
11
|
0
|
42
|
0
|
10
|
0
|
0
|
|
LTE Open Label Variable SC Dosing
COMPLETED
|
8
|
0
|
32
|
0
|
8
|
0
|
0
|
|
LTE Open Label Variable SC Dosing
NOT COMPLETED
|
3
|
0
|
10
|
0
|
2
|
0
|
0
|
|
LTE Open Label Fixed Dosing
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
48
|
|
LTE Open Label Fixed Dosing
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
35
|
|
LTE Open Label Fixed Dosing
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
13
|
Reasons for withdrawal
| Measure |
Group 1: 500 mg IV/75 mg SC
Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); body weight \< 60 kg. Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period) on Day 85 (IV abatacept based on their weight at screening; \< 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, \> 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
|
Group 2: 500 mg IV/125 mg SC
Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo;body weight \< 60 kg. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period; loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Variable Long term for 125 mg SC: body weight \<60 to \>100 kg. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
|
Group 3 : 750 mg IV/125 mg SC
Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo (body weight 60-100 kg). Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Variable Long term for 125 mg SC: body weight \<60 to \>100 kg). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
|
Group 4: 1000mg IV/125 mg SC
Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo; Body weight \> 100 kg. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period); variable long term for 125 mg SC: body weight \<60 to \>100 kg) . Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
|
Group 5: 1000 mg IV/200 mg SC
Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo; body weight \> 100 kg. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose based on weight as described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
|
Placebo
Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), by body weight. Long term extension (LTE) variable dosing period: all placebo participants rolled over to a variable dose of abatacept SC (75, 125, 200 mg) administered weekly following an IV loading dose of abatacept on Day 85. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
|
Fixed Dose 125 mg Abatacept
Participants who completed the variable dose long term extension (LTE)period and received variable doses of subcutaneous (SC) abatacept (75, 125, 200 mg SC) were rolled over into the LTE with fixed dose, irrespective of body weight: SC abatacept 125 milligram (mg) in pre-filled syringes, administered Weekly.
|
|---|---|---|---|---|---|---|---|
|
Short Term (12 Week) Randomized Dosing
Adverse Event
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Short Term (12 Week) Randomized Dosing
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Short Term (12 Week) Randomized Dosing
poor/non-compliance by participant
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
LTE Open Label Variable SC Dosing
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
LTE Open Label Variable SC Dosing
Adverse Event
|
1
|
0
|
2
|
0
|
1
|
0
|
0
|
|
LTE Open Label Variable SC Dosing
Lack of Efficacy
|
2
|
0
|
2
|
0
|
1
|
0
|
0
|
|
LTE Open Label Variable SC Dosing
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
LTE Open Label Variable SC Dosing
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
LTE Open Label Variable SC Dosing
Poor or non-compliance
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
LTE Open Label Variable SC Dosing
Other
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
LTE Open Label Fixed Dosing
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
LTE Open Label Fixed Dosing
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
LTE Open Label Fixed Dosing
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
LTE Open Label Fixed Dosing
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
LTE Open Label Fixed Dosing
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
LTE Open Label Fixed Dosing
Poor or non-compliance
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
LTE Open Label Fixed Dosing
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA)
Baseline characteristics by cohort
| Measure |
Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)
n=7 Participants
Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
|
Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)
n=4 Participants
Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
|
Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)
n=29 Participants
Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 ((IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 3 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
|
Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)
n=6 Participants
Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 4 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
|
Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)
n=5 Participants
Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
|
Placebo
n=17 Participants
Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks). Long term extension (LTE) variable dosing period: all placebo participants were rolled over to a variable dose of abatacept SC administered weekly following an IV loading dose of abatacept on Day 85.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 5 • n=5 Participants
|
64 years
STANDARD_DEVIATION 10 • n=7 Participants
|
59 years
STANDARD_DEVIATION 12 • n=5 Participants
|
51 years
STANDARD_DEVIATION 9 • n=4 Participants
|
55 years
STANDARD_DEVIATION 9 • n=21 Participants
|
59 years
STANDARD_DEVIATION 11 • n=10 Participants
|
60 years
STANDARD_DEVIATION 11 • n=115 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
57 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
29 participants
n=5 Participants
|
6 participants
n=4 Participants
|
5 participants
n=21 Participants
|
17 participants
n=10 Participants
|
68 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Days 71 to 85Population: 50 of the 51 abatacept-treated subjects were included. One subject who discontinued after receiving only Day 1 dosing was not included in this analysis.
Participants received abatacept while also receiving DMARDS over a short term (ST) 12 Week period. To eliminate contribution from the IV loading dose of abatacept during the short term study period, Cmin values were selected from Days 71 to 85, when contribution from IV was negligible. Minimum trough serum concentration of abatacept (Cmin) was measured in micrograms/milliliter (µg/mL). Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Outcome measures
| Measure |
Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)
n=5 Participants
Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
|
Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)
n=7 Participants
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)
n=4 Participants
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)
n=29 Participants
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)
n=5 Participants
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Placebo (by Body Weight Category)
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
|
|---|---|---|---|---|---|---|
|
Short Term Period: Steady-state Trough Serum Concentration (Cmin) of Abatacept Following Weekly Subcutaneous Dosing in Participants With Active Rheumatoid Arthritis Receiving Disease Modifying Anti-rheumatic Drugs (DMARDS)
Day 71
|
26.52 µg/mL
Geometric Coefficient of Variation 56.53
|
22.64 µg/mL
Geometric Coefficient of Variation 20.13
|
28.03 µg/mL
Geometric Coefficient of Variation 42.13
|
24.05 µg/mL
Geometric Coefficient of Variation 40.65
|
16.22 µg/mL
Geometric Coefficient of Variation 24.39
|
—
|
|
Short Term Period: Steady-state Trough Serum Concentration (Cmin) of Abatacept Following Weekly Subcutaneous Dosing in Participants With Active Rheumatoid Arthritis Receiving Disease Modifying Anti-rheumatic Drugs (DMARDS)
Day 78
|
29.21 µg/mL
Geometric Coefficient of Variation 52.96
|
21.66 µg/mL
Geometric Coefficient of Variation 19.99
|
34.17 µg/mL
Geometric Coefficient of Variation 29.49
|
24.41 µg/mL
Geometric Coefficient of Variation 52.35
|
11.57 µg/mL
Geometric Coefficient of Variation 32.25
|
—
|
|
Short Term Period: Steady-state Trough Serum Concentration (Cmin) of Abatacept Following Weekly Subcutaneous Dosing in Participants With Active Rheumatoid Arthritis Receiving Disease Modifying Anti-rheumatic Drugs (DMARDS)
Day 85
|
27.53 µg/mL
Geometric Coefficient of Variation 58.87
|
23.62 µg/mL
Geometric Coefficient of Variation 31.63
|
36.73 µg/mL
Geometric Coefficient of Variation 31.64
|
24.93 µg/mL
Geometric Coefficient of Variation 38.42
|
13.01 µg/mL
Geometric Coefficient of Variation 41.35
|
—
|
PRIMARY outcome
Timeframe: Day 85 to 56 days post last dosePopulation: Participants included those that rolled over into the LTE, receiving variable SC dosing of abatacept in the Variable Dose Period.
AEs during variable dose phase of LTE + 56 days post last dose in the variable dose phase or start of the fixed dose phase, which ever came first; includes deaths reported during the variable dose phase including those that occurred greater than 56 days after last dose. Medical Dictionary for Regulatory Activities (MedDRA) version: 15.1. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization (included hospitalizations for elective surgical procedures). Treatment-related=having certain, probable, possible, or missing relationship to study drug. Data presented by treatment the participant was randomized to and not what they actually received.
Outcome measures
| Measure |
Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)
Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
|
Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)
n=11 Participants
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)
n=42 Participants
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)
n=10 Participants
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Placebo (by Body Weight Category)
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Reported During the Variable Dosing Phase of the Long Term Period (LTE)
Participants with AEs
|
—
|
9 participants
|
38 participants
|
9 participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Reported During the Variable Dosing Phase of the Long Term Period (LTE)
Deaths
|
—
|
0 participants
|
1 participants
|
0 participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Reported During the Variable Dosing Phase of the Long Term Period (LTE)
Participants with SAEs
|
—
|
2 participants
|
13 participants
|
4 participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Reported During the Variable Dosing Phase of the Long Term Period (LTE)
Participants with drug related SAEs
|
—
|
1 participants
|
2 participants
|
1 participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Reported During the Variable Dosing Phase of the Long Term Period (LTE)
Participants discontinued due to SAEs
|
—
|
0 participants
|
1 participants
|
1 participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Reported During the Variable Dosing Phase of the Long Term Period (LTE)
Participants with drug related AEs
|
—
|
2 participants
|
20 participants
|
3 participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Reported During the Variable Dosing Phase of the Long Term Period (LTE)
Participants discontinued due to AEs
|
—
|
1 participants
|
2 participants
|
1 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 85 to Day 533Population: All 63 participants who completed the ST period enrolled into the LTE variable dosing period and were analyzed.
LTE period with variable abatacept dosing starting on Day 85 and continuing until Day 533 when LTE fixed dosing started. AEs of special interest: infection and/or infestation; neoplasms (malignant); pre-specified autoimmune disorder; infusional AEs (peri-infusional: pre-specified AEs occurring during first 24 hours (hrs) after start of the IV loading dose; acute infusional: pre-specified AEs occurring during the first hour after the start of the IV loading dose; systemic injection site reactions (SIR): pre-specified AEs for SIR; local injection site reaction: pre-specified AEs for local site reaction. Data are presented by treatment the participant was randomized to and not what they actually received.
Outcome measures
| Measure |
Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)
Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
|
Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)
n=11 Participants
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)
n=42 Participants
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)
n=10 Participants
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Placebo (by Body Weight Category)
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Pre-specified AEs of Special Interest in the Variable Dosing Phase of Long Term Extension (LTE)
Number with Serious Infection/Infestation
|
—
|
1 participants
|
1 participants
|
2 participants
|
—
|
—
|
|
Number of Participants With Pre-specified AEs of Special Interest in the Variable Dosing Phase of Long Term Extension (LTE)
Number with Malignant Neoplasms
|
—
|
1 participants
|
5 participants
|
1 participants
|
—
|
—
|
|
Number of Participants With Pre-specified AEs of Special Interest in the Variable Dosing Phase of Long Term Extension (LTE)
Number with Autoimmune Disorder
|
—
|
0 participants
|
1 participants
|
0 participants
|
—
|
—
|
|
Number of Participants With Pre-specified AEs of Special Interest in the Variable Dosing Phase of Long Term Extension (LTE)
Number with Acute Infusional Event
|
—
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
|
Number of Participants With Pre-specified AEs of Special Interest in the Variable Dosing Phase of Long Term Extension (LTE)
Number with Serious Systemic injection Reaction
|
—
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
|
Number of Participants With Pre-specified AEs of Special Interest in the Variable Dosing Phase of Long Term Extension (LTE)
Number with Local Injection Site Reaction
|
—
|
0 participants
|
4 participants
|
0 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 533 to 56 Days Post last dosePopulation: total number of participants in the Long Term Extension Period.
On Day 85 participants rolled over into the LTE with variable dose phase first and at Day 533, a fixed dose phase of 125 mg abatacept SC weekly, irrespective of body weight. This summary includes AEs reported during entire LTE treatment plus 56 days post last dose; includes all deaths reported during the LTE including those that occurred greater than 56 days after last dose. MedDRA version: 15.1. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization (also included hospitalizations for elective surgical procedures). Treatment-related=having certain, probable, possible, or missing relationship to study drug.
Outcome measures
| Measure |
Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)
Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
|
Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)
n=63 Participants
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Placebo (by Body Weight Category)
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Summarized Over the Entire Long Term Extension (LTE) Period (Both Variable and Fixed Dosing)
Participants with AEs
|
—
|
61 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Summarized Over the Entire Long Term Extension (LTE) Period (Both Variable and Fixed Dosing)
Participants with Drug Related AEs
|
—
|
34 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Summarized Over the Entire Long Term Extension (LTE) Period (Both Variable and Fixed Dosing)
Deaths
|
—
|
6 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Summarized Over the Entire Long Term Extension (LTE) Period (Both Variable and Fixed Dosing)
Participants with SAEs
|
—
|
35 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Summarized Over the Entire Long Term Extension (LTE) Period (Both Variable and Fixed Dosing)
Participants with Drug Related SAEs
|
—
|
7 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Summarized Over the Entire Long Term Extension (LTE) Period (Both Variable and Fixed Dosing)
Participants Discontinued due to SAEs
|
—
|
3 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Summarized Over the Entire Long Term Extension (LTE) Period (Both Variable and Fixed Dosing)
Participants Discontinued due to AEs
|
—
|
5 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 71 to Day 78Population: Pharmacokinetic (PK) analysis set included those participants treated with abatacept and having PK data available
Peak serum concentration (Cmax) of abatacept after weekly SC administration was determined between the SC dosing interval from Day 71 to 78. Abatacept in human serum was measured by enzyme-linked immunosorbent assay (ELISA). Lower limit of quantification (LLOQ) was 0.001, Upper limit of quantification (ULOQ) was 0.030. Cmax measured in micrograms per milliliter(µg/mL). Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Outcome measures
| Measure |
Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)
n=5 Participants
Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
|
Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)
n=7 Participants
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)
n=4 Participants
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)
n=26 Participants
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)
n=5 Participants
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Placebo (by Body Weight Category)
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
|
|---|---|---|---|---|---|---|
|
Short Term Period: Peak Serum Concentration (Cmax) of Abatacept at Steady State in Participants With Rheumatoid Arthritis Receiving DMARDS
|
41.7 µg/mL
Geometric Coefficient of Variation 41.2
|
26.3 µg/mL
Geometric Coefficient of Variation 29.5
|
34.9 µg/mL
Geometric Coefficient of Variation 46.6
|
31.9 µg/mL
Geometric Coefficient of Variation 42.8
|
14.7 µg/mL
Geometric Coefficient of Variation 44.3
|
—
|
SECONDARY outcome
Timeframe: Day 71 to Day 78Population: Pharmacokinetic (PK) analysis set included those participants treated with abatacept and having PK data available.
The steady-state pharmacokinetic parameter AUC(TAU) of abatacept after weekly SC administration was determined between the SC dosing interval from Day 71 to 78 (TAU=7 days). Abatacept in human serum was measured by enzyme-linked immunosorbent assay (ELISA). Lower limit of quantification (LLOQ) was 0.001; Upper limit of quantification (ULOQ) was 0.030. AUC(TAU) measured in in micrograms\*hours per milliliter (µg\*h/mL). Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Outcome measures
| Measure |
Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)
n=5 Participants
Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
|
Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)
n=7 Participants
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)
n=3 Participants
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)
n=24 Participants
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)
n=4 Participants
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Placebo (by Body Weight Category)
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
|
|---|---|---|---|---|---|---|
|
Short Term Period: Area Under the Curve (AUC) in Time Interval of 7 Days [AUC(TAU)] of Abatacept in Participants With Rheumatoid Arthritis Receiving DMARDS
|
5849 µg*h/mL
Geometric Coefficient of Variation 40.5
|
4066 µg*h/mL
Geometric Coefficient of Variation 22.2
|
6699 µg*h/mL
Geometric Coefficient of Variation 20.7
|
4607 µg*h/mL
Geometric Coefficient of Variation 38.6
|
2555 µg*h/mL
Geometric Coefficient of Variation 30.1
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 85 (or early termination)Number of Participants with Adverse events (AEs), Serious AEs, discontinuations due to AEs, or Deaths occurring while participant was on treatment from Day 1 (treatment) to Day 85 or early termination from the study. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization (also included hospitalizations for elective surgical procedures). Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Outcome measures
| Measure |
Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)
n=5 Participants
Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
|
Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)
n=7 Participants
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)
n=4 Participants
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)
n=29 Participants
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)
n=6 Participants
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Placebo (by Body Weight Category)
n=17 Participants
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
|
|---|---|---|---|---|---|---|
|
Short Term Period: Summary of Adverse Events (AEs), Serious AEs, Deaths, and Discontinuations Due to AEs During 12 Weeks of Treatment With Either Abatacept or Placebo
Participants with AEs
|
5 participants
|
5 participants
|
3 participants
|
21 participants
|
6 participants
|
11 participants
|
|
Short Term Period: Summary of Adverse Events (AEs), Serious AEs, Deaths, and Discontinuations Due to AEs During 12 Weeks of Treatment With Either Abatacept or Placebo
Discontinued due to AEs
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Short Term Period: Summary of Adverse Events (AEs), Serious AEs, Deaths, and Discontinuations Due to AEs During 12 Weeks of Treatment With Either Abatacept or Placebo
Deaths
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Short Term Period: Summary of Adverse Events (AEs), Serious AEs, Deaths, and Discontinuations Due to AEs During 12 Weeks of Treatment With Either Abatacept or Placebo
Participants with SAEs
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 85 (or early termination)Population: All subjects treated were analyzed for safety.
AEs of special interest: infection and/or infestation; neoplasms (benign, malignant, unspecified; autoimmune disorder; infusional AEs (peri-infusional: AEs occurring during first 24 hours (hrs) after start of the IV loading dose; acute infusional: AEs occurring during the first hour after the start of the IV loading dose; injection site AEs: AEs occurring at the site of the SC injection. Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Outcome measures
| Measure |
Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)
n=5 Participants
Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
|
Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)
n=7 Participants
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)
n=4 Participants
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)
n=29 Participants
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)
n=6 Participants
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Placebo (by Body Weight Category)
n=17 Participants
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
|
|---|---|---|---|---|---|---|
|
Short Term Period: Number of Participants With Pre-specified Adverse Events (AEs) of Special Interest After Administration of Abatacept or Placebo Over 12 Weeks
Number with malignant neoplasm events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Short Term Period: Number of Participants With Pre-specified Adverse Events (AEs) of Special Interest After Administration of Abatacept or Placebo Over 12 Weeks
Number with autoimmune disorder events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Short Term Period: Number of Participants With Pre-specified Adverse Events (AEs) of Special Interest After Administration of Abatacept or Placebo Over 12 Weeks
Number with acute infusional events
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
|
Short Term Period: Number of Participants With Pre-specified Adverse Events (AEs) of Special Interest After Administration of Abatacept or Placebo Over 12 Weeks
Number with peri-infusional events
|
0 participants
|
0 participants
|
0 participants
|
4 participants
|
3 participants
|
0 participants
|
|
Short Term Period: Number of Participants With Pre-specified Adverse Events (AEs) of Special Interest After Administration of Abatacept or Placebo Over 12 Weeks
General disorders and injection site events
|
2 participants
|
0 participants
|
1 participants
|
11 participants
|
3 participants
|
1 participants
|
|
Short Term Period: Number of Participants With Pre-specified Adverse Events (AEs) of Special Interest After Administration of Abatacept or Placebo Over 12 Weeks
Number with Infection/Infestation events
|
1 participants
|
3 participants
|
1 participants
|
9 participants
|
3 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 85 (or early termination)Population: Analysis set included all available data from participants who received abatacept or placebo. For RF analysis in Group 1 Day 1/Day 85 number of participants = 7/7; Group 2 = 3/3; Group 3 = 29/29; Group 4 = 6/6; Group 5 = 5/5; Placebo = 17/15 participants.
Serum samples were obtained on Days 1, 8, 15, 29, 57 and day of discharge (Day 85 or earlier) for determination of presence of rheumatoid factor (RF). Baseline was defined as Day 1 to calculate percent change. Lower limit of quantitation (LLQ) was 5 Units/milliliter (U/mL). Values below LLQ were set to 2.5 U/mL. Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Outcome measures
| Measure |
Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)
n=5 Participants
Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
|
Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)
n=7 Participants
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)
n=3 Participants
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)
n=29 Participants
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)
n=6 Participants
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Placebo (by Body Weight Category)
n=15 Participants
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
|
|---|---|---|---|---|---|---|
|
Short Term Period: Mean Percent Change From Baseline on Day 85 in Participants Positive for Serum Rheumatoid Factor During Abatacept or Placebo Administration
|
-19.32 percentage of change from baseline
Standard Deviation 15.21
|
-1.50 percentage of change from baseline
Standard Deviation 43.50
|
-8.89 percentage of change from baseline
Standard Deviation 3.14
|
-17.69 percentage of change from baseline
Standard Deviation 26.61
|
-16.29 percentage of change from baseline
Standard Deviation 16.24
|
43.72 percentage of change from baseline
Standard Deviation 154.47
|
SECONDARY outcome
Timeframe: Day 1 to Day 85 (or early termination)Population: All participants treated with either abatacept or placebo. Participant counted once in total for each arm but participant could have multiple AEs of different grade. Grade category is number of participants with that Grade of AE (Grades 1, 2, 3, 4)
Blood samples were obtained: At screening, within 24 hours prior to study drug administration on Day 1, on Days 15, 29, 57 and at study discharge. Baseline (BL) defined as Day 1 prior to treatment. Common toxicity criteria (CTC), Version 3 used to assess parameters. lower limit of normal (LLN). ANC=absolute neutrophil count. White blood cells Grade (Gr) 1:\<LLN to 3.0\*10\^9/L, Gr 2:\<3.0 to 2.0\*10\^9/L, Gr 3:\<2.0 to 1.0\*10\^9/L, Gr 4:\<1.0\*10\^9/L. ANC Gr 1:\<LLN to 1.5\*10\^9/L, Gr 2:\<1.5 to 1.0\*10\^9/L, Gr 3:\<1.0 to 0.5\*10\^9/L, Gr 4:\<0.5\*10\^9/L. Lymphocytes Gr 1: \<LLN to 3.0, Gr 2: 2.0 \< 3.0, Gr 3: 1.0 to \< 2.0, Gr 4; \< 1.0. Platelet count Gr 1:LLN to 75.0\*10\^9/L, Gr 2:\<75.0 to 50.0\*10\^9/L, Gr 3:\<50.0 to 25.0\*10\^9/L, Gr 4:\<25.0 to 10\^9/L. Hemoglobin Gr 1:\<LLN to 10.0 g/dL, Gr 2:\<10.0 to 8.0 g/dL, Gr 3:\<8.0 to 6.5 g/dL, Gr 4:\<6.5 g/dL. Hematocrit (%): \<0.75\*pre-treatment. Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Outcome measures
| Measure |
Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)
n=5 Participants
Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
|
Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)
n=7 Participants
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)
n=4 Participants
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)
n=29 Participants
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)
n=6 Participants
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Placebo (by Body Weight Category)
n=17 Participants
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
|
|---|---|---|---|---|---|---|
|
Short Term Period: Number of Participants With Laboratory Abnormalities in Hematology at Baseline (Day 1) to End of Period (Day 85)
Baseline (Day 1 prior to treatment) Total
|
2 participants
|
4 participants
|
3 participants
|
15 participants
|
1 participants
|
9 participants
|
|
Short Term Period: Number of Participants With Laboratory Abnormalities in Hematology at Baseline (Day 1) to End of Period (Day 85)
Grade 1 baseline
|
2 participants
|
4 participants
|
3 participants
|
13 participants
|
1 participants
|
8 participants
|
|
Short Term Period: Number of Participants With Laboratory Abnormalities in Hematology at Baseline (Day 1) to End of Period (Day 85)
Grade 4 baseline
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Short Term Period: Number of Participants With Laboratory Abnormalities in Hematology at Baseline (Day 1) to End of Period (Day 85)
Day 1 after treatment to Day 85 Total
|
4 participants
|
4 participants
|
4 participants
|
20 participants
|
1 participants
|
13 participants
|
|
Short Term Period: Number of Participants With Laboratory Abnormalities in Hematology at Baseline (Day 1) to End of Period (Day 85)
Grade 3 on treatment
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Short Term Period: Number of Participants With Laboratory Abnormalities in Hematology at Baseline (Day 1) to End of Period (Day 85)
Grade 2 baseline
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
3 participants
|
|
Short Term Period: Number of Participants With Laboratory Abnormalities in Hematology at Baseline (Day 1) to End of Period (Day 85)
Grade 3 baseline
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Short Term Period: Number of Participants With Laboratory Abnormalities in Hematology at Baseline (Day 1) to End of Period (Day 85)
Grade 1 on treatment
|
3 participants
|
4 participants
|
4 participants
|
17 participants
|
1 participants
|
11 participants
|
|
Short Term Period: Number of Participants With Laboratory Abnormalities in Hematology at Baseline (Day 1) to End of Period (Day 85)
Grade 2 on treatment
|
1 participants
|
0 participants
|
1 participants
|
6 participants
|
0 participants
|
3 participants
|
|
Short Term Period: Number of Participants With Laboratory Abnormalities in Hematology at Baseline (Day 1) to End of Period (Day 85)
Grade 4 on treatment
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 85 (or early termination)Population: All participants treated with abatacept or placebo in the short term period. Participant is counted once in total but could have multiple AEs of different grade. Grade category is number of participants with that Grade of AE (Grades 1, 2, 3, 4)
Screening, BL, Days 15, 29, 57, 85 or discharge. Upper limit of normal (ULN). CTC grade (Gr): Alanine transaminase Gr 1:\>ULN to 2.5\*ULN; Gr 2: \>2.5 to 5.0\*ULN; Gr 3: \>5.0 to 20.0\*ULN; Gr 4: \>20.0\*ULN. Aspartate aminotransferase Gr 1: \>ULN to 2.5\*ULN; Gr 2:\>2.5 to 5.0\*ULN; Gr 3: \>5.0 to 20.0\*ULN; Gr 4: \>20.0\*ULN. G-Glutamyl Transferase (U/L) Gr 1:\>ULN to 2.5\*ULN; Gr 2: \>2.5 to 5.0\*ULN; Gr 3: \>5.0 to 20.0\*ULN; Gr 4: \>20.0\*ULN. Alkaline phosphatase (U/L) Gr 1:\>ULN to 2.5\*ULN, Gr2:\>2.5 to 5.0\*ULN, Gr3:\>5.0 to 20.0\*ULN, Gr4: \>20.0\*ULN; creatinine (mg/dL) Gr 1: \>ULN to 1.5\*ULN; Gr 2: \>1.5 to 3.0\*ULN; Gr 3: \>3.0 to 6.0\*ULN; Gr 4: \>10.0\*ULN. Albumin (g/dL) Gr 1:\<LLN to 3.0; Gr 2:\<3.0 to 2.0; Gr 3: \<2.0. Uric Acid (mg/dL)Gr 1: \>1.0 x ULN to 10.0; Gr 4: \>10.0. Sodium (mEq/L) Gr 1: \>ULN to 150; Gr 2: \>150 to 155; Gr 3: \>155 to 160; Gr 4: \> 160. Potassium (mEq/L) Gr 1: \>ULN to 5.5; Gr 2: \>5.5 to 6.0; Gr 3: \>6.0 to 7.0; Gr 4: \>7.0. Data presented by treatment participant actually received.
Outcome measures
| Measure |
Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)
n=5 Participants
Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
|
Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)
n=7 Participants
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)
n=4 Participants
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)
n=29 Participants
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)
n=6 Participants
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Placebo (by Body Weight Category)
n=17 Participants
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
|
|---|---|---|---|---|---|---|
|
Short Term Period: Number of Participants With Laboratory Abnormalities in Serum Chemistry at Baseline and on Treatment up to Day 85
Grade 2 baseline
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Short Term Period: Number of Participants With Laboratory Abnormalities in Serum Chemistry at Baseline and on Treatment up to Day 85
Grade 3 on treatment
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Short Term Period: Number of Participants With Laboratory Abnormalities in Serum Chemistry at Baseline and on Treatment up to Day 85
Baseline (Day 1 prior to treatment) Total
|
4 participants
|
2 participants
|
2 participants
|
6 participants
|
1 participants
|
7 participants
|
|
Short Term Period: Number of Participants With Laboratory Abnormalities in Serum Chemistry at Baseline and on Treatment up to Day 85
Grade 1 baseline
|
4 participants
|
2 participants
|
2 participants
|
5 participants
|
1 participants
|
7 participants
|
|
Short Term Period: Number of Participants With Laboratory Abnormalities in Serum Chemistry at Baseline and on Treatment up to Day 85
Grade 3 baseline
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Short Term Period: Number of Participants With Laboratory Abnormalities in Serum Chemistry at Baseline and on Treatment up to Day 85
Grade 4 baseline
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Short Term Period: Number of Participants With Laboratory Abnormalities in Serum Chemistry at Baseline and on Treatment up to Day 85
Day 1 (after treatment) to Day 85 Total
|
4 participants
|
5 participants
|
4 participants
|
18 participants
|
3 participants
|
15 participants
|
|
Short Term Period: Number of Participants With Laboratory Abnormalities in Serum Chemistry at Baseline and on Treatment up to Day 85
Grade 1 on treatment
|
3 participants
|
5 participants
|
0 participants
|
18 participants
|
3 participants
|
15 participants
|
|
Short Term Period: Number of Participants With Laboratory Abnormalities in Serum Chemistry at Baseline and on Treatment up to Day 85
Grade 2 on treatment
|
0 participants
|
1 participants
|
0 participants
|
4 participants
|
0 participants
|
4 participants
|
|
Short Term Period: Number of Participants With Laboratory Abnormalities in Serum Chemistry at Baseline and on Treatment up to Day 85
Grade 4 on treatment
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 85 (or early termination)Population: All participants who were treated with abatacept or placebo and had vital signs taken were analyzed throughout the 12 weeks. At Day 85 N = 6, 3, 28,6, 5, 17 in groups 1, 2, 3, 4, 5, Placebo, respectively
Blood pressure (systolic and diastolic) was recorded while the participant was seated during the screening visit, at baseline on Day 1 (prior to administration of IV infusion), prior to administration of all SC injections, and at study discharge (Day 85 or 7 days after the last dose for subjects who terminated early). In addition, blood pressure was recorded at 30 and 60 minutes after the start of the IV infusion on Day 1, and 30 and 60 minutes after all SC injections. Blood pressure was measured in millimeters of mercury (mm Hg). Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Outcome measures
| Measure |
Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)
n=5 Participants
Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
|
Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)
n=7 Participants
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)
n=4 Participants
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)
n=29 Participants
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)
n=6 Participants
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Placebo (by Body Weight Category)
n=17 Participants
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
|
|---|---|---|---|---|---|---|
|
Short Term Period: Mean Change From Baseline at Day 85 in Blood Pressure After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS
Change from baseline in Diastolic blood pressure
|
-5.4 mm Hg
Standard Deviation 9.6
|
-5.2 mm Hg
Standard Deviation 10.0
|
0.0 mm Hg
Standard Deviation 13.1
|
0.7 mm Hg
Standard Deviation 7.5
|
3.5 mm Hg
Standard Deviation 11.2
|
1.8 mm Hg
Standard Deviation 8.3
|
|
Short Term Period: Mean Change From Baseline at Day 85 in Blood Pressure After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS
Change from baseline in Systolic blood pressure
|
-4.2 mm Hg
Standard Deviation 10.5
|
-4.0 mm Hg
Standard Deviation 12.1
|
-6.3 mm Hg
Standard Deviation 6.8
|
0.3 mm Hg
Standard Deviation 17.8
|
-0.8 mm Hg
Standard Deviation 8.2
|
0.2 mm Hg
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: Day 1 to Day 85 (or early termination)Population: All participants who were treated with abatacept or placebo and had vital signs taken were analyzed throughout the 12 weeks. At Day 85 N = 6, 3, 28, 6, 5, 17 in groups 1, 2, 3, 4, 5, Placebo, respectively
Pulse rate was taken while participant was seated. Pulse rate was recorded during the screening visit, at baseline on Day 1 (prior to administration of IV infusion), prior to administration of all SC injections, and at study discharge (Day 85 or 7 days after the last dose for subjects who terminated early). In addition, vital signs were recorded at 30 and 60 minutes after the start of the IV infusion on Day 1, and 30 and 60 minutes after all SC injections. Pulse rate measured in beats/min (bpm). Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Outcome measures
| Measure |
Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)
n=5 Participants
Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
|
Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)
n=7 Participants
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)
n=4 Participants
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)
n=29 Participants
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)
n=6 Participants
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Placebo (by Body Weight Category)
n=17 Participants
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
|
|---|---|---|---|---|---|---|
|
Short Term Period: Mean Change From Baseline at Day 85 in Pulse Rate After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS
|
-11.4 bpm
Standard Deviation 9.0
|
-2.9 bpm
Standard Deviation 10.0
|
0.3 bpm
Standard Deviation 11.1
|
-0.6 bpm
Standard Deviation 9.5
|
3.5 bpm
Standard Deviation 10.5
|
-1.0 bpm
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: Screening to Day 85 (or early termination)Population: A total of 68 participants were treated with abatacept or placebo: 66 had results at screening and 52 had results at Discharge (Day 85) for QT interval and QRS Width; 65 and 51 participants had PR interval results at Screening and Discharge (Day 85), respectively.
A 12-lead electrocardiogram (ECG) was recorded at screening and at discharge from the study (Day 85 or 7 days after the last dose of study drug for those subjects who terminated early). If there was no history of known cardiac events, an ECG was performed within 6 months of study entry, and documentation was on file, then the screening ECG was not repeated at screening. QT interval, PR interval and QRW Width were reported in milliseconds (msec). If no ECG issues were found in the 12 weeks of the Short Term Period, ECG was not repeated during LTE. Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Outcome measures
| Measure |
Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)
Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
|
Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)
n=66 Participants
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Placebo (by Body Weight Category)
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
|
|---|---|---|---|---|---|---|
|
Short Term Period: Mean Change From Screening to Day 85 in Electrocardiogram (QT, PR Intervals, QRS Width) After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS
Change from Screening in PR interval (N=51)
|
—
|
5.28 msec
Standard Deviation 21.10
|
—
|
—
|
—
|
—
|
|
Short Term Period: Mean Change From Screening to Day 85 in Electrocardiogram (QT, PR Intervals, QRS Width) After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS
Change from Screening in QT interval (N=52)
|
—
|
-1.47 msec
Standard Deviation 24.72
|
—
|
—
|
—
|
—
|
|
Short Term Period: Mean Change From Screening to Day 85 in Electrocardiogram (QT, PR Intervals, QRS Width) After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS
Change from Screening in QRS Width (N=52)
|
—
|
0.22 msec
Standard Deviation 11.03
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening to Day 85 (or early termination)Population: A total of 68 participants were treated with abatacept or placebo: 65 had results at screening and 53 had results at Discharge (Day 85) for Heart Rate.
A 12-lead electrocardiogram (ECG) was recorded at screening and at discharge from the study (Day 85 or 7 days after the last dose of study drug for those subjects who terminated early). If there was no history of known cardiac events, an ECG was performed within 6 months of study entry, and documentation was on file, then the screening ECG was not repeated at screening. Heart Rate was reported in beats per minute (bpm). In no ECG issues were found in the 12 weeks of the Short Term Period, ECG was not repeated during LTE. Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Outcome measures
| Measure |
Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)
Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
|
Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)
n=53 Participants
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Placebo (by Body Weight Category)
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
|
|---|---|---|---|---|---|---|
|
Short Term Period: Mean Change From Screening at Day 85 in ECG (Heart Rate) After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS
|
—
|
0.51 bpm
Standard Deviation 8.43
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: ST: Day 1 to Day 85; LTE: Day 85 to 168 days post last dosePopulation: In the ST period, only subjects treated with abatacept (51) were evaluated for antibodies. In LTE, 61 participants were analyzed for anti-abatacept antibodies, and 62 participants were analyzed for CTLA4-T antibodies. Participants were analyzed during treatment and post-treatment (28, 56, 85, and 168 days post-treatment).
Assessment of positive antibody response based upon analysis using a validated enzyme-linked immunosorbent assay (ELISA) with a cut-off value. CTLA4 is a protein receptor that downregulates the immune system. Short Term (ST) period was initial 12 Weeks of the study. Overall LTE includes both the variable and fixed abatacept dosing periods and was from the end of the ST period (Day 85) up to 168 days post last dose (treatment in LTE ranged from 4.4 to 74.2 months. Data in the ST period are summarized by the treatment the participants actually received, while the LT period data are summarized by treatment the participant was randomized to receive.
Outcome measures
| Measure |
Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)
n=5 Participants
Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
|
Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)
n=7 Participants
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)
n=4 Participants
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)
n=29 Participants
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)
n=6 Participants
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
|
Placebo (by Body Weight Category)
n=62 Participants
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
|
|---|---|---|---|---|---|---|
|
Overall Study ST and LTE Periods: Number of Participants With Anti-abatacept Antibodies and/or Anti-cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibodies
Number with anti-abatacept antibodies
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
11 participants
|
|
Overall Study ST and LTE Periods: Number of Participants With Anti-abatacept Antibodies and/or Anti-cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibodies
Number with anti-CTLA4 antibodies
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
Adverse Events
Abatacept 1000mg IV/125mg SC
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Abatacept 1000mg IV/200mg SC
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Abatacept 500mg IV/125mg SC
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Abatacept 500mg IV/75mg SC
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Abatacept 750mg IV/125mg SC
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Abatacept (LT) 125 mg SC
Serious events: 35 serious events
Other events: 58 other events
Deaths: 0 deaths
Placebo (ST)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abatacept 1000mg IV/125mg SC
n=6 participants at risk
Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
|
Abatacept 1000mg IV/200mg SC
n=5 participants at risk
Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose based on weight as described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
|
Abatacept 500mg IV/125mg SC
n=5 participants at risk
Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period; loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
|
Abatacept 500mg IV/75mg SC
n=6 participants at risk
Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept based on their weight at screening; \< 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, \> 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
|
Abatacept 750mg IV/125mg SC
n=28 participants at risk
Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
|
Abatacept (LT) 125 mg SC
n=63 participants at risk
Participants who completed the long term extension (LTE)period and received variable doses of subcutaneous (SC) abatacept (as described in Groups 1 - 5) were rolled over into the LTE with fixed dose: SC abatacept 125 milligram (mg) in pre-filled syringes, administered Weekly.
|
Placebo (ST)
n=18 participants at risk
Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks). Long term extension (LTE) variable dosing period: all placebo participants rolled over to a variable dose of abatacept SC (75, 125, 200 mg) administered weekly following an IV loading dose of abatacept on Day 85. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Injection site reaction
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm malignant stage unspecified
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
11.1%
7/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
General disorders
Chest discomfort
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
General disorders
Death
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.2%
2/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.2%
2/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
6.3%
4/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.2%
2/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Infections and infestations
Wound infection
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.0%
1/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.2%
2/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.2%
2/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
General disorders
Impaired healing
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Infections and infestations
Meningitis
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.2%
2/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.2%
2/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
6.3%
4/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
7.9%
5/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
4.8%
3/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
General disorders
Chest pain
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Cardiac disorders
Diastolic dysfunction
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
6.3%
4/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
Other adverse events
| Measure |
Abatacept 1000mg IV/125mg SC
n=6 participants at risk
Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
|
Abatacept 1000mg IV/200mg SC
n=5 participants at risk
Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose based on weight as described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
|
Abatacept 500mg IV/125mg SC
n=5 participants at risk
Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period; loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
|
Abatacept 500mg IV/75mg SC
n=6 participants at risk
Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept based on their weight at screening; \< 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, \> 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
|
Abatacept 750mg IV/125mg SC
n=28 participants at risk
Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
|
Abatacept (LT) 125 mg SC
n=63 participants at risk
Participants who completed the long term extension (LTE)period and received variable doses of subcutaneous (SC) abatacept (as described in Groups 1 - 5) were rolled over into the LTE with fixed dose: SC abatacept 125 milligram (mg) in pre-filled syringes, administered Weekly.
|
Placebo (ST)
n=18 participants at risk
Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks). Long term extension (LTE) variable dosing period: all placebo participants rolled over to a variable dose of abatacept SC (75, 125, 200 mg) administered weekly following an IV loading dose of abatacept on Day 85. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
|
|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
7.1%
2/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.2%
2/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.6%
13/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
5.6%
1/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
General disorders
Chest discomfort
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
6.3%
4/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
5.6%
1/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
7.9%
5/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
7.9%
5/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
7.1%
2/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
4.8%
3/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.0%
1/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
11.1%
7/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
5.6%
1/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
4.8%
3/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.2%
2/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
5.6%
1/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
7.9%
5/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
7.9%
5/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
6.3%
4/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.0%
1/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
7.1%
2/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
4.8%
3/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
12.7%
8/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
5.6%
1/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
6.3%
4/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
22.2%
14/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
5.6%
1/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
7.9%
5/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
5.6%
1/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
12.7%
8/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
10.7%
3/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
22.2%
14/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
16.7%
3/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
General disorders
Chills
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
7.1%
2/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
7.1%
2/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.6%
13/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.2%
2/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
5.6%
1/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
14.3%
9/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
General disorders
Injection site reaction
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
10.7%
3/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
6.3%
4/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
11.1%
7/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
6.3%
4/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
6.3%
4/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.0%
1/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
7.1%
2/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
6.3%
4/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
9.5%
6/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Eye disorders
Cataract
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
12.7%
8/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.0%
1/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
6.3%
4/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
7.9%
5/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
16.7%
3/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.0%
1/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.0%
1/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
5.6%
1/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
General disorders
Injection site haematoma
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.0%
1/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
9.5%
6/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
6.3%
4/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
17.5%
11/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
33.3%
2/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
11.1%
7/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.0%
1/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
7.1%
2/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
15.9%
10/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
5.6%
1/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.0%
1/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
7.9%
5/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
5.6%
1/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
5.6%
1/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.0%
1/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
7.1%
2/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
12.7%
8/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
11.1%
2/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
6.3%
4/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
40.0%
2/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
12.7%
8/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
16.7%
3/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
9.5%
6/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
7.9%
5/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
General disorders
Injection site warmth
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
7.1%
2/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
General disorders
Oedema peripheral
|
33.3%
2/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.0%
1/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
19.0%
12/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
6.3%
4/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.0%
1/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
6.3%
4/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
10.7%
3/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
34.9%
22/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
11.1%
2/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
14.3%
4/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.6%
13/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Eye disorders
Vision blurred
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
4.8%
3/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
5.6%
1/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
General disorders
Asthenia
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.0%
1/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
4.8%
3/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
6.3%
4/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Metabolism and nutrition disorders
Fluid retention
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
6.3%
4/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.2%
2/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
5.6%
1/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.0%
1/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
11.1%
7/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
5.6%
1/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
4.8%
3/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
5.6%
1/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Vascular disorders
Phlebitis superficial
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.0%
1/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Skin and subcutaneous tissue disorders
Scab
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
6.3%
4/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
7.1%
2/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Infections and infestations
Viral infection
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
5.6%
1/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
11.1%
7/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Eye disorders
Glaucoma
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.2%
2/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
General disorders
Injection site erythema
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.0%
1/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
5.6%
1/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
General disorders
Injection site pain
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.0%
1/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
10.7%
3/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
5.6%
1/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
General disorders
Injection site swelling
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
20.0%
1/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
5.6%
1/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.6%
1/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
12.7%
8/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
3.2%
2/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
5.6%
1/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
6.3%
4/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
1.6%
1/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
7.1%
2/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
7.9%
5/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Nervous system disorders
Sinus headache
|
16.7%
1/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/5 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/6 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/28 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
6.3%
4/63 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
0.00%
0/18 • Day 1 of short term study up to 71 months in the long term study.
AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER