Trial Outcomes & Findings for Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1) (NCT NCT01963611)
NCT ID: NCT01963611
Last Updated: 2016-05-11
Results Overview
Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions per Subject and Scan was calculated using 5 serial magnetic resonance imaging (MRI) scans.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
255 participants
Primary outcome timeframe
Baseline , Week 12, 24, 28, 32, 36, 40
Results posted on
2016-05-11
Participant Flow
Participant milestones
| Measure |
Plovamer Acetate 0.5 Milligram (mg)
Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 3 mg
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 10 mg
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 20 mg
Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
|
Copaxone 20 mg
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
49
|
52
|
52
|
51
|
|
Overall Study
Safety Analysis Set
|
51
|
49
|
52
|
52
|
50
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
51
|
49
|
52
|
52
|
51
|
Reasons for withdrawal
| Measure |
Plovamer Acetate 0.5 Milligram (mg)
Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 3 mg
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 10 mg
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 20 mg
Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
|
Copaxone 20 mg
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
3
|
4
|
3
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
1
|
1
|
3
|
|
Overall Study
Other
|
47
|
46
|
48
|
45
|
45
|
Baseline Characteristics
Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)
Baseline characteristics by cohort
| Measure |
Plovamer Acetate 0.5 Milligram (mg)
n=51 Participants
Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 3 mg
n=49 Participants
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 10 mg
n=52 Participants
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 20 mg
n=52 Participants
Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
|
Copaxone 20 mg
n=50 Participants
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
|
Total
n=254 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 10.73 • n=99 Participants
|
40.7 years
STANDARD_DEVIATION 9.54 • n=107 Participants
|
41.1 years
STANDARD_DEVIATION 10.83 • n=206 Participants
|
40.4 years
STANDARD_DEVIATION 9.53 • n=7 Participants
|
41.8 years
STANDARD_DEVIATION 11.61 • n=31 Participants
|
40.6 years
STANDARD_DEVIATION 10.43 • n=30 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
26 Participants
n=31 Participants
|
177 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
77 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline , Week 12, 24, 28, 32, 36, 40Population: Intent to Treat (ITT) analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions per Subject and Scan was calculated using 5 serial magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Plovamer Acetate 0.5 Milligram (mg)
n=45 Participants
Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 3 mg
n=45 Participants
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 10 mg
n=43 Participants
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 20 mg
n=41 Participants
Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
|
Copaxone 20 mg
n=44 Participants
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
|
|---|---|---|---|---|---|
|
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Baseline (n=44,45,42,41,44)
|
1.5 lesions per subjects per scan
Standard Deviation 2.93
|
1.6 lesions per subjects per scan
Standard Deviation 4.12
|
1.0 lesions per subjects per scan
Standard Deviation 2.43
|
2.3 lesions per subjects per scan
Standard Deviation 5.65
|
2.5 lesions per subjects per scan
Standard Deviation 5.12
|
|
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Week 12: (n=44,45,43,41,44)
|
1.7 lesions per subjects per scan
Standard Deviation 3.28
|
1.3 lesions per subjects per scan
Standard Deviation 3.55
|
1.2 lesions per subjects per scan
Standard Deviation 2.40
|
1.5 lesions per subjects per scan
Standard Deviation 3.70
|
1.7 lesions per subjects per scan
Standard Deviation 4.51
|
|
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Week 24: (n=17,17,21,18,19)
|
1.5 lesions per subjects per scan
Standard Deviation 2.53
|
0.9 lesions per subjects per scan
Standard Deviation 2.33
|
1.5 lesions per subjects per scan
Standard Deviation 4.14
|
1.1 lesions per subjects per scan
Standard Deviation 1.92
|
0.6 lesions per subjects per scan
Standard Deviation 1.46
|
|
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Week 28: (n=10,11,13,12,13)
|
1.7 lesions per subjects per scan
Standard Deviation 2.75
|
0.4 lesions per subjects per scan
Standard Deviation 0.92
|
0.5 lesions per subjects per scan
Standard Deviation 1.20
|
2.0 lesions per subjects per scan
Standard Deviation 4.00
|
0.9 lesions per subjects per scan
Standard Deviation 1.89
|
|
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Week 32: (n=5,6,9,10,9)
|
1.0 lesions per subjects per scan
Standard Deviation 1.41
|
0.2 lesions per subjects per scan
Standard Deviation 0.41
|
0.8 lesions per subjects per scan
Standard Deviation 1.72
|
1.8 lesions per subjects per scan
Standard Deviation 3.33
|
1.2 lesions per subjects per scan
Standard Deviation 3.67
|
|
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Week 36: (n=1,0,2,3,3)
|
0.0 lesions per subjects per scan
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
NA lesions per subjects per scan
Standard Deviation NA
Data was not reported as there was no subject.
|
1.0 lesions per subjects per scan
Standard Deviation 1.41
|
1.3 lesions per subjects per scan
Standard Deviation 2.31
|
7.3 lesions per subjects per scan
Standard Deviation 12.70
|
|
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Week 40: (n=1,0,1,1,1)
|
0.0 lesions per subjects per scan
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
NA lesions per subjects per scan
Standard Deviation NA
Data was not reported as there was no subject.
|
0.0 lesions per subjects per scan
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
0.0 lesions per subjects per scan
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
16.0 lesions per subjects per scan
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
SECONDARY outcome
Timeframe: Baseline up to Week 40Population: Safety Analysis Set (SAF) includes all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP).
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (\>=) 1 grade in \>=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of \>=2 grades in 1 functional scale of the EDSS or an increase of \>= 0.5 or an increase of \>=1.0 in EDSS if the previous EDSS was 0. Annualized Relapse Rate was calculated as = 365.25 x (Number of relapses during Treatment Period) per (Number of days on treatment during Treatment Period).
Outcome measures
| Measure |
Plovamer Acetate 0.5 Milligram (mg)
n=51 Participants
Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 3 mg
n=49 Participants
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 10 mg
n=52 Participants
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 20 mg
n=52 Participants
Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
|
Copaxone 20 mg
n=50 Participants
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
|
|---|---|---|---|---|---|
|
Mean Annualized Relapse Rate (ARR)
|
0.3 percent relapse
Standard Deviation 0.88
|
0.2 percent relapse
Standard Deviation 0.62
|
0.2 percent relapse
Standard Deviation 0.76
|
0.2 percent relapse
Standard Deviation 0.88
|
0.2 percent relapse
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: Baseline up to Week 40Population: Safety Analysis Set (SAF) includes all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP).
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (\>=) 1 grade in \>=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of \>=2 grades in 1 functional scale of the EDSS or an increase of \>= 0.5 or an increase of \>=1.0 in EDSS if the previous EDSS was 0.
Outcome measures
| Measure |
Plovamer Acetate 0.5 Milligram (mg)
n=51 Participants
Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 3 mg
n=49 Participants
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 10 mg
n=52 Participants
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 20 mg
n=52 Participants
Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
|
Copaxone 20 mg
n=50 Participants
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
|
|---|---|---|---|---|---|
|
Percentage of Subjects Remaining Relapse-Free
|
86.3 percent subjects
|
89.8 percent subjects
|
94.2 percent subjects
|
94.2 percent subjects
|
90.0 percent subjects
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 28, 32, 36, 40Population: ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here "n" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
T1 Gd-enhancing lesions per subject and scan was measured using 5 serial MRI scans.
Outcome measures
| Measure |
Plovamer Acetate 0.5 Milligram (mg)
n=45 Participants
Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 3 mg
n=45 Participants
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 10 mg
n=43 Participants
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 20 mg
n=41 Participants
Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
|
Copaxone 20 mg
n=44 Participants
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
|
|---|---|---|---|---|---|
|
Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Week 12: (n=44,45,43,41,44)
|
1.7 lesions/subject/scan
Standard Deviation 3.26
|
1.2 lesions/subject/scan
Standard Deviation 3.54
|
1.2 lesions/subject/scan
Standard Deviation 2.26
|
1.3 lesions/subject/scan
Standard Deviation 2.99
|
1.6 lesions/subject/scan
Standard Deviation 4.31
|
|
Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Week 24: (n=17,17,21,18,19)
|
1.5 lesions/subject/scan
Standard Deviation 2.53
|
0.9 lesions/subject/scan
Standard Deviation 2.33
|
1.4 lesions/subject/scan
Standard Deviation 3.56
|
1.0 lesions/subject/scan
Standard Deviation 1.94
|
0.5 lesions/subject/scan
Standard Deviation 1.26
|
|
Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Week 28: (n=10,11,13,12,13)
|
1.2 lesions/subject/scan
Standard Deviation 2.15
|
0.1 lesions/subject/scan
Standard Deviation 0.30
|
0.5 lesions/subject/scan
Standard Deviation 1.13
|
1.8 lesions/subject/scan
Standard Deviation 3.83
|
0.5 lesions/subject/scan
Standard Deviation 1.33
|
|
Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Week 32: (n=5,6,9,10,9)
|
0.8 lesions/subject/scan
Standard Deviation 1.10
|
0.2 lesions/subject/scan
Standard Deviation 0.41
|
0.4 lesions/subject/scan
Standard Deviation 1.33
|
1.5 lesions/subject/scan
Standard Deviation 2.95
|
0.6 lesions/subject/scan
Standard Deviation 1.67
|
|
Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Week 36: (n=1,0,2,3,3)
|
0.0 lesions/subject/scan
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
NA lesions/subject/scan
Standard Deviation NA
Data was not reported as there was no subject.
|
0.5 lesions/subject/scan
Standard Deviation 0.71
|
1.0 lesions/subject/scan
Standard Deviation 1.73
|
5.7 lesions/subject/scan
Standard Deviation 9.81
|
|
Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Week 40: (n=1,0,1,1,1)
|
0.0 lesions/subject/scan
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
NA lesions/subject/scan
Standard Deviation NA
Data was not reported as there was no subject.
|
0.0 lesions/subject/scan
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
0.0 lesions/subject/scan
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
16.0 lesions/subject/scan
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 28, 32, 36,40Population: ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
New or enlarging Time Constant 2 (T2) lesions per subject and scan was calculated using 5 serial MRI scans.
Outcome measures
| Measure |
Plovamer Acetate 0.5 Milligram (mg)
n=45 Participants
Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 3 mg
n=45 Participants
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 10 mg
n=43 Participants
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 20 mg
n=41 Participants
Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
|
Copaxone 20 mg
n=44 Participants
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
|
|---|---|---|---|---|---|
|
Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan
Week 12: (n=44,45,43,41,44)
|
4.5 lesions/subject/scan
Standard Deviation 7.41
|
2.6 lesions/subject/scan
Standard Deviation 4.99
|
2.7 lesions/subject/scan
Standard Deviation 4.50
|
4.1 lesions/subject/scan
Standard Deviation 7.45
|
4.0 lesions/subject/scan
Standard Deviation 8.59
|
|
Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan
Week 24: (n=17,17,21,18,19)
|
3.1 lesions/subject/scan
Standard Deviation 5.61
|
1.8 lesions/subject/scan
Standard Deviation 3.35
|
2.3 lesions/subject/scan
Standard Deviation 4.91
|
3.4 lesions/subject/scan
Standard Deviation 6.03
|
1.7 lesions/subject/scan
Standard Deviation 3.45
|
|
Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan
Week 28: (n=10,11,13,12,13)
|
1.3 lesions/subject/scan
Standard Deviation 2.45
|
0.2 lesions/subject/scan
Standard Deviation 0.40
|
0.8 lesions/subject/scan
Standard Deviation 1.69
|
2.5 lesions/subject/scan
Standard Deviation 5.05
|
0.8 lesions/subject/scan
Standard Deviation 2.15
|
|
Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan
Week 32: (n=5,6,9,10,9)
|
1.4 lesions/subject/scan
Standard Deviation 2.19
|
0.2 lesions/subject/scan
Standard Deviation 0.41
|
0.3 lesions/subject/scan
Standard Deviation 0.71
|
2.4 lesions/subject/scan
Standard Deviation 4.12
|
0.9 lesions/subject/scan
Standard Deviation 2.32
|
|
Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan
Week 36: (n=1,0,2,3,3)
|
0.0 lesions/subject/scan
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
NA lesions/subject/scan
Standard Deviation NA
Data was not reported as there was no subject.
|
0.5 lesions/subject/scan
Standard Deviation 0.71
|
1.7 lesions/subject/scan
Standard Deviation 2.89
|
4.3 lesions/subject/scan
Standard Deviation 7.51
|
|
Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan
Week 40: (n=1,0,1,1,1)
|
0.0 lesions/subject/scan
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
NA lesions/subject/scan
Standard Deviation NA
Data was not reported as there was no subject.
|
0.0 lesions/subject/scan
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
0.0 lesions/subject/scan
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
13.0 lesions/subject/scan
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 28, 32, 36, 40Population: ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
New, unenhancing T1 lesions (Black Holes) per subject and scan was calculated using 5 Serial MRIs.
Outcome measures
| Measure |
Plovamer Acetate 0.5 Milligram (mg)
n=45 Participants
Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 3 mg
n=45 Participants
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 10 mg
n=43 Participants
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 20 mg
n=41 Participants
Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
|
Copaxone 20 mg
n=44 Participants
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
|
|---|---|---|---|---|---|
|
Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan
Week 12: (n=44,45,43,41,44)
|
2.8 lesions/subject/scan
Standard Deviation 6.48
|
1.8 lesions/subject/scan
Standard Deviation 3.97
|
1.4 lesions/subject/scan
Standard Deviation 2.21
|
2.6 lesions/subject/scan
Standard Deviation 5.24
|
2.6 lesions/subject/scan
Standard Deviation 5.13
|
|
Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan
Week 24: (n=17,17,21,18,19)
|
2.0 lesions/subject/scan
Standard Deviation 4.80
|
0.8 lesions/subject/scan
Standard Deviation 1.55
|
0.8 lesions/subject/scan
Standard Deviation 1.83
|
1.3 lesions/subject/scan
Standard Deviation 2.89
|
0.8 lesions/subject/scan
Standard Deviation 1.75
|
|
Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan
Week 28: (n=10,11,13,12,13)
|
0.6 lesions/subject/scan
Standard Deviation 1.26
|
0.2 lesions/subject/scan
Standard Deviation 0.60
|
0.6 lesions/subject/scan
Standard Deviation 1.56
|
0.5 lesions/subject/scan
Standard Deviation 1.00
|
0.4 lesions/subject/scan
Standard Deviation 1.39
|
|
Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan
Week 32: (n=5,6,9,10,9)
|
2.0 lesions/subject/scan
Standard Deviation 3.39
|
0.2 lesions/subject/scan
Standard Deviation 0.41
|
0.8 lesions/subject/scan
Standard Deviation 1.30
|
0.7 lesions/subject/scan
Standard Deviation 1.25
|
0.3 lesions/subject/scan
Standard Deviation 0.71
|
|
Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan
Week 36: (n=1,0,2,3,3)
|
0.0 lesions/subject/scan
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
NA lesions/subject/scan
Standard Deviation NA
Data was not reported as there was no subject.
|
0.0 lesions/subject/scan
Standard Deviation 0.00
|
0.7 lesions/subject/scan
Standard Deviation 1.15
|
1.7 lesions/subject/scan
Standard Deviation 2.89
|
|
Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan
Week 40: (n=1,0,1,1,1)
|
0.0 lesions/subject/scan
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
NA lesions/subject/scan
Standard Deviation NA
Data was not reported as there was no subject.
|
0.0 lesions/subject/scan
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
0.0 lesions/subject/scan
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
11.0 lesions/subject/scan
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 28, 32, 36, 40Population: ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
Change from baseline in volume of T1 Gd-enhancing lesions per subject was calculated using 5 Serial MRI Scans.
Outcome measures
| Measure |
Plovamer Acetate 0.5 Milligram (mg)
n=45 Participants
Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 3 mg
n=45 Participants
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 10 mg
n=43 Participants
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 20 mg
n=41 Participants
Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
|
Copaxone 20 mg
n=44 Participants
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Baseline: (n=44,45,42,41,44)
|
0.182 cubic millimeter (mm^3)
Standard Deviation 0.4212
|
0.209 cubic millimeter (mm^3)
Standard Deviation 0.6325
|
0.138 cubic millimeter (mm^3)
Standard Deviation 0.3577
|
0.508 cubic millimeter (mm^3)
Standard Deviation 1.1981
|
0.264 cubic millimeter (mm^3)
Standard Deviation 0.5707
|
|
Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Change at Week 12: (n=44,45,42,41,44)
|
0.037 cubic millimeter (mm^3)
Standard Deviation 0.3982
|
-0.007 cubic millimeter (mm^3)
Standard Deviation 0.6019
|
0.189 cubic millimeter (mm^3)
Standard Deviation 0.8406
|
-0.190 cubic millimeter (mm^3)
Standard Deviation 1.0389
|
0.023 cubic millimeter (mm^3)
Standard Deviation 0.5794
|
|
Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Change at Week 24: (n=16,17,20,18,19)
|
0.053 cubic millimeter (mm^3)
Standard Deviation 0.1705
|
0.352 cubic millimeter (mm^3)
Standard Deviation 1.4308
|
0.060 cubic millimeter (mm^3)
Standard Deviation 0.4858
|
-0.591 cubic millimeter (mm^3)
Standard Deviation 1.4910
|
-0.250 cubic millimeter (mm^3)
Standard Deviation 0.5393
|
|
Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Change at Week 28: (n=9,11,12,12,13)
|
0.224 cubic millimeter (mm^3)
Standard Deviation 0.2948
|
0.067 cubic millimeter (mm^3)
Standard Deviation 0.4640
|
0.057 cubic millimeter (mm^3)
Standard Deviation 0.5728
|
-0.796 cubic millimeter (mm^3)
Standard Deviation 1.7779
|
-0.257 cubic millimeter (mm^3)
Standard Deviation 0.6980
|
|
Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Change at Week 32: (n=4,6,8,10,9)
|
-0.085 cubic millimeter (mm^3)
Standard Deviation 0.2765
|
-0.102 cubic millimeter (mm^3)
Standard Deviation 0.2691
|
-0.135 cubic millimeter (mm^3)
Standard Deviation 0.6305
|
-0.988 cubic millimeter (mm^3)
Standard Deviation 1.9800
|
0.031 cubic millimeter (mm^3)
Standard Deviation 0.8312
|
|
Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Change at Week 36: (n=0,0,1,3,3)
|
NA cubic millimeter (mm^3)
Standard Deviation NA
Data was not reported as there was no subject.
|
NA cubic millimeter (mm^3)
Standard Deviation NA
Data was not reported as there was no subject.
|
0.321 cubic millimeter (mm^3)
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
-1.881 cubic millimeter (mm^3)
Standard Deviation 3.4679
|
0.834 cubic millimeter (mm^3)
Standard Deviation 2.1816
|
|
Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Change at Week 40: (n=0,0,0,1,1)
|
NA cubic millimeter (mm^3)
Standard Deviation NA
Data was not reported as there was no subject.
|
NA cubic millimeter (mm^3)
Standard Deviation NA
Data was not reported as there was no subject.
|
NA cubic millimeter (mm^3)
Standard Deviation NA
Data was not reported as there was no subject.
|
0.000 cubic millimeter (mm^3)
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
2.180 cubic millimeter (mm^3)
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 28, 32, 36, 40Population: ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
Change from baseline per subjects in volume of T2 Gd-enhancing lesions was calculated using 5 series MRI scan.
Outcome measures
| Measure |
Plovamer Acetate 0.5 Milligram (mg)
n=45 Participants
Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 3 mg
n=45 Participants
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 10 mg
n=43 Participants
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
|
Plovamer Acetate 20 mg
n=41 Participants
Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
|
Copaxone 20 mg
n=44 Participants
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Baseline (n=44,45,42,41,44)
|
12.240 cubic millimeter (mm^3)
Standard Deviation 14.6956
|
13.482 cubic millimeter (mm^3)
Standard Deviation 19.0522
|
11.364 cubic millimeter (mm^3)
Standard Deviation 16.0282
|
9.518 cubic millimeter (mm^3)
Standard Deviation 13.2248
|
11.616 cubic millimeter (mm^3)
Standard Deviation 15.4960
|
|
Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Change at Week 12: (n=44,45,42,41,44)
|
0.443 cubic millimeter (mm^3)
Standard Deviation 2.2414
|
0.397 cubic millimeter (mm^3)
Standard Deviation 1.0399
|
0.686 cubic millimeter (mm^3)
Standard Deviation 2.4894
|
-0.200 cubic millimeter (mm^3)
Standard Deviation 4.5312
|
0.060 cubic millimeter (mm^3)
Standard Deviation 1.3886
|
|
Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Change at Week 24: (n=16,17,20,18,19)
|
-0.179 cubic millimeter (mm^3)
Standard Deviation 2.2741
|
0.871 cubic millimeter (mm^3)
Standard Deviation 2.7803
|
0.113 cubic millimeter (mm^3)
Standard Deviation 1.2011
|
-1.734 cubic millimeter (mm^3)
Standard Deviation 6.8085
|
-0.907 cubic millimeter (mm^3)
Standard Deviation 2.5627
|
|
Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Change at Week 28: (n=9,11,12,12,13)
|
0.016 cubic millimeter (mm^3)
Standard Deviation 3.2248
|
0.858 cubic millimeter (mm^3)
Standard Deviation 3.0417
|
0.306 cubic millimeter (mm^3)
Standard Deviation 1.1945
|
-2.610 cubic millimeter (mm^3)
Standard Deviation 8.3108
|
-1.379 cubic millimeter (mm^3)
Standard Deviation 3.4251
|
|
Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Change at Week 32: (n=4,6,8,10,9)
|
0.874 cubic millimeter (mm^3)
Standard Deviation 2.4859
|
0.163 cubic millimeter (mm^3)
Standard Deviation 1.2524
|
-0.106 cubic millimeter (mm^3)
Standard Deviation 1.3423
|
-3.246 cubic millimeter (mm^3)
Standard Deviation 9.3533
|
-1.867 cubic millimeter (mm^3)
Standard Deviation 3.6432
|
|
Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Change at Week 36: (n=0,0,1,3,3)
|
NA cubic millimeter (mm^3)
Standard Deviation NA
Data was not reported as there was no subject.
|
NA cubic millimeter (mm^3)
Standard Deviation NA
Data was not reported as there was no subject.
|
1.236 cubic millimeter (mm^3)
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
-10.324 cubic millimeter (mm^3)
Standard Deviation 17.2227
|
-4.433 cubic millimeter (mm^3)
Standard Deviation 4.6895
|
|
Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Change at Week 40: (n=0,0,0,1,1)
|
NA cubic millimeter (mm^3)
Standard Deviation NA
Data was not reported as there was no subject.
|
NA cubic millimeter (mm^3)
Standard Deviation NA
Data was not reported as there was no subject.
|
NA cubic millimeter (mm^3)
Standard Deviation NA
Data was not reported as there was no subject.
|
-29.965 cubic millimeter (mm^3)
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
-10.661 cubic millimeter (mm^3)
Standard Deviation NA
Standard deviation was not reported as number of subject analyzed was 1.
|
SECONDARY outcome
Timeframe: Baseline up to Week 40Population: The Outcome Measure was not derived due to early termination of the study.
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (\>=) 1 grade in \>=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of \>=2 grades in 1 functional scale of the EDSS or an increase of \>= 0.5 or an increase of \>=1.0 in EDSS if the previous EDSS was 0.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 24, 28, 32, 36, 40Population: The Outcome Measure was not derived due to early termination of the study.
Change from baseline in brain volume per subject was calculated using 5 series MRI scan.
Outcome measures
Outcome data not reported
Adverse Events
Plovamer Acetate 0.5 Milligram (mg)
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Plovamer Acetate 3 mg
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Plovamer Acetate 10 mg
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
Plovamer Acetate 20 mg
Serious events: 3 serious events
Other events: 41 other events
Deaths: 0 deaths
Copaxone 20 mg
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Plovamer Acetate 0.5 Milligram (mg)
n=51 participants at risk
Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for a minimum of 40 weeks.
|
Plovamer Acetate 3 mg
n=49 participants at risk
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for a minimum of 40 weeks.
|
Plovamer Acetate 10 mg
n=52 participants at risk
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for a minimum of 40 weeks.
|
Plovamer Acetate 20 mg
n=52 participants at risk
Plovamer acetate was administered at a dose of 20 mg as weekly subcutaneous injection for a minimum of 40 weeks.
|
Copaxone 20 mg
n=50 participants at risk
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for a minimum of 40 weeks.
|
|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Psychiatric disorders
Major depression
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Vascular disorders
Venous thrombosis
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Influenza like illness
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
Other adverse events
| Measure |
Plovamer Acetate 0.5 Milligram (mg)
n=51 participants at risk
Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for a minimum of 40 weeks.
|
Plovamer Acetate 3 mg
n=49 participants at risk
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for a minimum of 40 weeks.
|
Plovamer Acetate 10 mg
n=52 participants at risk
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for a minimum of 40 weeks.
|
Plovamer Acetate 20 mg
n=52 participants at risk
Plovamer acetate was administered at a dose of 20 mg as weekly subcutaneous injection for a minimum of 40 weeks.
|
Copaxone 20 mg
n=50 participants at risk
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for a minimum of 40 weeks.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
11.5%
6/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
5.8%
3/52 • Baseline up to end of treatment (week 40)
|
8.0%
4/50 • Baseline up to end of treatment (week 40)
|
|
Infections and infestations
Urinary tract infection
|
3.9%
2/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
Infections and infestations
Bronchitis
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Infections and infestations
Cystitis
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
3.8%
2/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
4.1%
2/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
3.8%
2/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Infections and infestations
Erythema migrans
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
3.8%
2/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Infections and infestations
Ear infection
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Infections and infestations
Herpes zoster
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Infections and infestations
Influenza
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Infections and infestations
Laryngitis
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Infections and infestations
Tracheitis
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Infections and infestations
Urethritis
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
Psychiatric disorders
Depression
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
3.8%
2/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
4.1%
2/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Psychiatric disorders
Anxiety
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
4.1%
2/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Psychiatric disorders
Mood altered
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Nervous system disorders
Headache
|
7.8%
4/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
7.7%
4/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
3.8%
2/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Nervous system disorders
Essential tremor
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Nervous system disorders
Paraesthesia
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Nervous system disorders
Radicular pain
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
Nervous system disorders
Perineurial cyst
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
Eye disorders
Eyelid skin dryness
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Eye disorders
Iritis
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Eye disorders
Vision blurred
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Vascular disorders
Hypertension
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Gastrointestinal disorders
Nausea
|
3.9%
2/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
3.8%
2/52 • Baseline up to end of treatment (week 40)
|
3.8%
2/52 • Baseline up to end of treatment (week 40)
|
4.0%
2/50 • Baseline up to end of treatment (week 40)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
4.1%
2/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Gastrointestinal disorders
Melanosis coli
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
3/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Musculoskeletal and connective tissue disorders
Myokymia
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Renal and urinary disorders
Urinary incontinence
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Injection site pain
|
15.7%
8/51 • Baseline up to end of treatment (week 40)
|
40.8%
20/49 • Baseline up to end of treatment (week 40)
|
50.0%
26/52 • Baseline up to end of treatment (week 40)
|
50.0%
26/52 • Baseline up to end of treatment (week 40)
|
56.0%
28/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Injection site erythema
|
19.6%
10/51 • Baseline up to end of treatment (week 40)
|
32.7%
16/49 • Baseline up to end of treatment (week 40)
|
26.9%
14/52 • Baseline up to end of treatment (week 40)
|
36.5%
19/52 • Baseline up to end of treatment (week 40)
|
36.0%
18/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Injection site pruritus
|
5.9%
3/51 • Baseline up to end of treatment (week 40)
|
12.2%
6/49 • Baseline up to end of treatment (week 40)
|
19.2%
10/52 • Baseline up to end of treatment (week 40)
|
7.7%
4/52 • Baseline up to end of treatment (week 40)
|
30.0%
15/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Injection site induration
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
4.1%
2/49 • Baseline up to end of treatment (week 40)
|
9.6%
5/52 • Baseline up to end of treatment (week 40)
|
11.5%
6/52 • Baseline up to end of treatment (week 40)
|
8.0%
4/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Injection site oedema
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
3.8%
2/52 • Baseline up to end of treatment (week 40)
|
3.8%
2/52 • Baseline up to end of treatment (week 40)
|
4.0%
2/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Injection site bruising
|
5.9%
3/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
6.0%
3/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Influenza like illness
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Injection site haematoma
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
3.8%
2/52 • Baseline up to end of treatment (week 40)
|
8.0%
4/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Injection site laceration
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Injection site nodule
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
3.8%
2/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Injection site rash
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Pyrexia
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
3.8%
2/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Asthenia
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Chest discomfort
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Chills
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Fatigue
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
3.8%
2/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Injection site paraesthesia
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Injection site swelling
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Oedema peripheral
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Chest pain
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Inflammation
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Injection site cyst
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Injection site mass
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Peripheral swelling
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Cyst
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Hyperthermia
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Injection site discolouration
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Injection site granuloma
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
General disorders
Pain
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
3.8%
2/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
4.0%
2/50 • Baseline up to end of treatment (week 40)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Investigations
Electrocardiogram PR shortened
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Investigations
Liver function test abnormal
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Injury, poisoning and procedural complications
Head injury
|
2.0%
1/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
2.0%
1/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
1.9%
1/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/50 • Baseline up to end of treatment (week 40)
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/51 • Baseline up to end of treatment (week 40)
|
0.00%
0/49 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
0.00%
0/52 • Baseline up to end of treatment (week 40)
|
2.0%
1/50 • Baseline up to end of treatment (week 40)
|
Additional Information
Merck KGaA Communication Center
Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER