Trial Outcomes & Findings for Long-Term Efficacy and Safety Extension Study of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome) (NCT NCT01415427)
NCT ID: NCT01415427
Last Updated: 2021-07-21
Results Overview
Efficacy was assessed by changes from baseline in 6-minute walk test
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
173 participants
Primary outcome timeframe
Baseline to week 168
Results posted on
2021-07-21
Participant Flow
Participant milestones
| Measure |
PBO-QOW
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
|
PBO-QW
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
|
QOW-QOW
Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
|
QW-QW
Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
59
|
56
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
29
|
29
|
58
|
56
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long-Term Efficacy and Safety Extension Study of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome)
Baseline characteristics by cohort
| Measure |
PBO-QOW
n=29 Participants
Placebo in MOR004 + BMN110 2.0 mg/kg/qow in MOR005
|
PBO-QW
n=29 Participants
Placebo in MOR004 + BMN110 2.0 mg/kg/qw in MOR005
|
QOW-QOW
n=59 Participants
BMN110 2.0 mg/kg/qow in MOR004 + BMN110 2.0 mg/kg/qow in MOR005
|
QW-QW
n=56 Participants
BMN110 2.0 mg/kg/qw in MOR004 + BMN110 2.0 mg/kg/qw in MOR005
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
16.7 years
STANDARD_DEVIATION 13.66 • n=93 Participants
|
13.5 years
STANDARD_DEVIATION 8.50 • n=4 Participants
|
15.3 years
STANDARD_DEVIATION 10.79 • n=27 Participants
|
12.8 years
STANDARD_DEVIATION 8.01 • n=483 Participants
|
14.4 years
STANDARD_DEVIATION 10.20 • n=36 Participants
|
|
Age, Customized
5 - 11
|
15 participants
n=93 Participants
|
15 participants
n=4 Participants
|
31 participants
n=27 Participants
|
32 participants
n=483 Participants
|
93 participants
n=36 Participants
|
|
Age, Customized
12 - 18
|
7 participants
n=93 Participants
|
7 participants
n=4 Participants
|
16 participants
n=27 Participants
|
16 participants
n=483 Participants
|
46 participants
n=36 Participants
|
|
Age, Customized
>=19
|
7 participants
n=93 Participants
|
7 participants
n=4 Participants
|
12 participants
n=27 Participants
|
8 participants
n=483 Participants
|
34 participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
87 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
86 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
37 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
47 Participants
n=483 Participants
|
136 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 participants
n=93 Participants
|
7 participants
n=4 Participants
|
15 participants
n=27 Participants
|
14 participants
n=483 Participants
|
40 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
2 participants
n=27 Participants
|
2 participants
n=483 Participants
|
4 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White
|
25 participants
n=93 Participants
|
18 participants
n=4 Participants
|
35 participants
n=27 Participants
|
35 participants
n=483 Participants
|
113 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=93 Participants
|
4 participants
n=4 Participants
|
7 participants
n=27 Participants
|
5 participants
n=483 Participants
|
16 participants
n=36 Participants
|
|
Region of Enrollment
Argentina
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
2 participants
n=36 Participants
|
|
Region of Enrollment
Brazil
|
2 participants
n=93 Participants
|
3 participants
n=4 Participants
|
10 participants
n=27 Participants
|
5 participants
n=483 Participants
|
20 participants
n=36 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=93 Participants
|
1 participants
n=4 Participants
|
5 participants
n=27 Participants
|
5 participants
n=483 Participants
|
14 participants
n=36 Participants
|
|
Region of Enrollment
Colombia
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
2 participants
n=483 Participants
|
6 participants
n=36 Participants
|
|
Region of Enrollment
Denmark
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
1 participants
n=36 Participants
|
|
Region of Enrollment
France
|
2 participants
n=93 Participants
|
5 participants
n=4 Participants
|
5 participants
n=27 Participants
|
8 participants
n=483 Participants
|
20 participants
n=36 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
5 participants
n=27 Participants
|
1 participants
n=483 Participants
|
10 participants
n=36 Participants
|
|
Region of Enrollment
Italy
|
3 participants
n=93 Participants
|
1 participants
n=4 Participants
|
4 participants
n=27 Participants
|
2 participants
n=483 Participants
|
10 participants
n=36 Participants
|
|
Region of Enrollment
Japan
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
4 participants
n=27 Participants
|
2 participants
n=483 Participants
|
6 participants
n=36 Participants
|
|
Region of Enrollment
Korea, South
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
3 participants
n=483 Participants
|
7 participants
n=36 Participants
|
|
Region of Enrollment
Netherlands
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
2 participants
n=27 Participants
|
3 participants
n=483 Participants
|
6 participants
n=36 Participants
|
|
Region of Enrollment
Portugal
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
3 participants
n=36 Participants
|
|
Region of Enrollment
Qatar
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
2 participants
n=36 Participants
|
|
Region of Enrollment
Saudi Arabia
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
1 participants
n=27 Participants
|
4 participants
n=483 Participants
|
7 participants
n=36 Participants
|
|
Region of Enrollment
Taiwan
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
3 participants
n=27 Participants
|
1 participants
n=483 Participants
|
5 participants
n=36 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=93 Participants
|
3 participants
n=4 Participants
|
4 participants
n=27 Participants
|
9 participants
n=483 Participants
|
22 participants
n=36 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=93 Participants
|
5 participants
n=4 Participants
|
11 participants
n=27 Participants
|
9 participants
n=483 Participants
|
32 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 168Population: ITT-intent-to-treat population, defined as all patients enrolled in the study who received patient IDs regardless of whether they received study drug or not.
Efficacy was assessed by changes from baseline in 6-minute walk test
Outcome measures
| Measure |
PBO-QOW
n=29 Participants
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
|
PBO-QW
n=29 Participants
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
|
QOW-QOW
n=59 Participants
Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
|
QW-QW
n=58 Participants
Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
|
Total
n=176 Participants
All treatment groups
|
|---|---|---|---|---|---|
|
Change From Baseline in 6-minute Walk (6MW) Test - ITT
Baseline
|
219.7 meters
Standard Deviation 74.22
|
207.2 meters
Standard Deviation 64.87
|
205.7 meters
Standard Deviation 81.19
|
203.9 meters
Standard Deviation 76.32
|
207.2 meters
Standard Deviation 75.58
|
|
Change From Baseline in 6-minute Walk (6MW) Test - ITT
Change from Baseline to Week 120
|
32.3 meters
Standard Deviation 92.13
|
-2.9 meters
Standard Deviation 95.69
|
6.0 meters
Standard Deviation 86.28
|
29.7 meters
Standard Deviation 81.37
|
16.9 meters
Standard Deviation 87.67
|
|
Change From Baseline in 6-minute Walk (6MW) Test - ITT
Change from Baseline to Week 24
|
23.8 meters
Standard Deviation 56.21
|
5.0 meters
Standard Deviation 43.27
|
11.1 meters
Standard Deviation 49.95
|
36.5 meters
Standard Deviation 58.49
|
20.2 meters
Standard Deviation 54.02
|
|
Change From Baseline in 6-minute Walk (6MW) Test - ITT
Change from Baseline to Week 72
|
41.5 meters
Standard Deviation 89.24
|
-1.5 meters
Standard Deviation 112.07
|
27.2 meters
Standard Deviation 56.66
|
30.6 meters
Standard Deviation 73.66
|
26.1 meters
Standard Deviation 79.26
|
|
Change From Baseline in 6-minute Walk (6MW) Test - ITT
Change from Baseline to Week 168
|
52.2 meters
Standard Deviation 100.07
|
20.1 meters
Standard Deviation 80.79
|
5.2 meters
Standard Deviation 81.54
|
-8.8 meters
Standard Deviation 101.24
|
8.9 meters
Standard Deviation 90.81
|
PRIMARY outcome
Timeframe: Baseline to week 168Population: MPP- modified per-protocol population, define as the ITT(intent to treat) after removing patients who had orthosurgery in first 120 weeks or \<96 doses in first 120 weeks.
Efficacy was assessed by changes from baseline in 6-minute walk test
Outcome measures
| Measure |
PBO-QOW
n=20 Participants
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
|
PBO-QW
n=19 Participants
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
|
QOW-QOW
n=42 Participants
Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
|
QW-QW
n=43 Participants
Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
|
Total
n=124 Participants
All treatment groups
|
|---|---|---|---|---|---|
|
Change From Baseline in 6-minute Walk (6MW) Test - MPP
Change from Baseline to Week 72
|
54.5 meters
Standard Deviation 85.19
|
37.7 meters
Standard Deviation 69.35
|
35.3 meters
Standard Deviation 58.19
|
37.5 meters
Standard Deviation 72.17
|
39.6 meters
Standard Deviation 69.11
|
|
Change From Baseline in 6-minute Walk (6MW) Test - MPP
Change from Baseline to Week 120
|
60.8 meters
Standard Deviation 64.45
|
19.8 meters
Standard Deviation 86.69
|
19.7 meters
Standard Deviation 77.29
|
38.6 meters
Standard Deviation 66.65
|
33.0 meters
Standard Deviation 73.94
|
|
Change From Baseline in 6-minute Walk (6MW) Test - MPP
Baseline
|
208.7 meters
Standard Deviation 78.12
|
190.2 meters
Standard Deviation 65.54
|
195.9 meters
Standard Deviation 80.40
|
208.8 meters
Standard Deviation 73.24
|
201.6 meters
Standard Deviation 74.94
|
|
Change From Baseline in 6-minute Walk (6MW) Test - MPP
Change from Baseline to Week 24
|
30.3 meters
Standard Deviation 56.53
|
9.6 meters
Standard Deviation 46.87
|
13.6 meters
Standard Deviation 52.65
|
41.5 meters
Standard Deviation 59.89
|
25.4 meters
Standard Deviation 56.08
|
|
Change From Baseline in 6-minute Walk (6MW) Test - MPP
Change from Baseline to Week 168
|
85.8 meters
Standard Deviation 128.04
|
14.6 meters
Standard Deviation 94.41
|
10.0 meters
Standard Deviation 84.66
|
-12.3 meters
Standard Deviation 106.34
|
8.8 meters
Standard Deviation 98.69
|
SECONDARY outcome
Timeframe: Baseline to week 168Population: ITT-intent-to-treat population, defined as all patients enrolled in the study who received patient IDs regardless of whether they received study drug or not
Efficacy was assessed by changes from baseline in 3-minute stair climb test.
Outcome measures
| Measure |
PBO-QOW
n=29 Participants
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
|
PBO-QW
n=29 Participants
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
|
QOW-QOW
n=59 Participants
Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
|
QW-QW
n=58 Participants
Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
|
Total
n=176 Participants
All treatment groups
|
|---|---|---|---|---|---|
|
Change From Baseline in 3-minute Stair Climb Test - ITT
Baseline
|
33.1 stairs/min
Standard Deviation 15.60
|
26.9 stairs/min
Standard Deviation 12.08
|
27.1 stairs/min
Standard Deviation 15.80
|
29.6 stairs/min
Standard Deviation 16.44
|
28.9 stairs/min
Standard Deviation 15.42
|
|
Change From Baseline in 3-minute Stair Climb Test - ITT
Change from Baseline to Week 24
|
4.7 stairs/min
Standard Deviation 9.65
|
2.9 stairs/min
Standard Deviation 7.30
|
2.9 stairs/min
Standard Deviation 10.94
|
4.8 stairs/min
Standard Deviation 8.06
|
3.8 stairs/min
Standard Deviation 9.25
|
|
Change From Baseline in 3-minute Stair Climb Test - ITT
Change from Baseline to Week 72
|
8.9 stairs/min
Standard Deviation 15.44
|
1.2 stairs/min
Standard Deviation 14.95
|
5.5 stairs/min
Standard Deviation 11.96
|
5.3 stairs/min
Standard Deviation 9.88
|
5.3 stairs/min
Standard Deviation 12.60
|
|
Change From Baseline in 3-minute Stair Climb Test - ITT
Change from Baseline to Week 120
|
6.0 stairs/min
Standard Deviation 17.05
|
1.7 stairs/min
Standard Deviation 14.80
|
4.7 stairs/min
Standard Deviation 14.60
|
5.8 stairs/min
Standard Deviation 13.42
|
4.8 stairs/min
Standard Deviation 14.65
|
|
Change From Baseline in 3-minute Stair Climb Test - ITT
Change from baseline to week 168
|
8.9 stairs/min
Standard Deviation 17.57
|
5.5 stairs/min
Standard Deviation 15.44
|
4.6 stairs/min
Standard Deviation 13.64
|
0.4 stairs/min
Standard Deviation 20.96
|
4.0 stairs/min
Standard Deviation 16.90
|
SECONDARY outcome
Timeframe: Baseline to week 168Population: MPP- modified per-protocol population, define as the ITT(intent to treat) after removing patients who had orthosurgery in first 120 weeks or \<96 doses in first 120 weeks
Efficacy was assessed by changes from baseline in 3-minute stair climb test.
Outcome measures
| Measure |
PBO-QOW
n=20 Participants
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
|
PBO-QW
n=19 Participants
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
|
QOW-QOW
n=42 Participants
Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
|
QW-QW
n=43 Participants
Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
|
Total
n=124 Participants
All treatment groups
|
|---|---|---|---|---|---|
|
Change From Baseline in 3-minute Stair Climb Test - MPP
Change from Baseline to Week 24
|
3.4 stairs/min
Standard Deviation 8.09
|
3.6 stairs/min
Standard Deviation 8.63
|
5.0 stairs/min
Standard Deviation 11.46
|
3.9 stairs/min
Standard Deviation 7.67
|
4.1 stairs/min
Standard Deviation 9.23
|
|
Change From Baseline in 3-minute Stair Climb Test - MPP
Change from Baseline to Week 72
|
10.4 stairs/min
Standard Deviation 13.77
|
6.1 stairs/min
Standard Deviation 10.56
|
7.4 stairs/min
Standard Deviation 12.53
|
5.7 stairs/min
Standard Deviation 9.98
|
7.1 stairs/min
Standard Deviation 11.61
|
|
Change From Baseline in 3-minute Stair Climb Test - MPP
Baseline
|
33.1 stairs/min
Standard Deviation 14.12
|
24.8 stairs/min
Standard Deviation 13.92
|
25.6 stairs/min
Standard Deviation 13.73
|
31.3 stairs/min
Standard Deviation 16.22
|
28.7 stairs/min
Standard Deviation 14.93
|
|
Change From Baseline in 3-minute Stair Climb Test - MPP
Change from Baseline to Week 120
|
9.1 stairs/min
Standard Deviation 13.38
|
4.2 stairs/min
Standard Deviation 12.49
|
8.1 stairs/min
Standard Deviation 13.83
|
7.2 stairs/min
Standard Deviation 12.58
|
7.4 stairs/min
Standard Deviation 13.05
|
|
Change From Baseline in 3-minute Stair Climb Test - MPP
Change from baseline to week 168
|
12.4 stairs/min
Standard Deviation 23.03
|
4.3 stairs/min
Standard Deviation 17.82
|
6.0 stairs/min
Standard Deviation 14.59
|
-2.6 stairs/min
Standard Deviation 18.47
|
3.3 stairs/min
Standard Deviation 17.39
|
SECONDARY outcome
Timeframe: Baseline to week 168Population: ITT-intent-to-treat population, defined as all patients enrolled in the study who received patient IDs regardless of whether they received study drug or not
Efficacy was assessed by changes from baseline in urine keratan sulfate (normalized to urine creatinine.)
Outcome measures
| Measure |
PBO-QOW
n=29 Participants
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
|
PBO-QW
n=29 Participants
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
|
QOW-QOW
n=59 Participants
Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
|
QW-QW
n=58 Participants
Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
|
Total
n=176 Participants
All treatment groups
|
|---|---|---|---|---|---|
|
Change From Baseline in Urine Keratan Sulfate - ITT
Percent Change from Baseline to Week 120
|
-55.5 ug/mg
Standard Deviation 18.60
|
-62.2 ug/mg
Standard Deviation 15.39
|
-55.8 ug/mg
Standard Deviation 26.56
|
-61.5 ug/mg
Standard Deviation 20.59
|
-58.7 ug/mg
Standard Deviation 21.88
|
|
Change From Baseline in Urine Keratan Sulfate - ITT
Baseline
|
22.7 ug/mg
Standard Deviation 15.27
|
28.5 ug/mg
Standard Deviation 14.89
|
28.6 ug/mg
Standard Deviation 21.17
|
26.9 ug/mg
Standard Deviation 14.11
|
27.1 ug/mg
Standard Deviation 17.05
|
|
Change From Baseline in Urine Keratan Sulfate - ITT
Percent Change from Baseline to Week 24
|
3.4 ug/mg
Standard Deviation 29.15
|
-11.3 ug/mg
Standard Deviation 23.68
|
-35.2 ug/mg
Standard Deviation 20.70
|
-45.1 ug/mg
Standard Deviation 19.89
|
-28.2 ug/mg
Standard Deviation 28.46
|
|
Change From Baseline in Urine Keratan Sulfate - ITT
Percent Change from Baseline to Week 72
|
-54.1 ug/mg
Standard Deviation 17.21
|
-56.8 ug/mg
Standard Deviation 13.69
|
-55.6 ug/mg
Standard Deviation 14.23
|
-53.7 ug/mg
Standard Deviation 17.45
|
-55.0 ug/mg
Standard Deviation 15.61
|
|
Change From Baseline in Urine Keratan Sulfate - ITT
Percent Change from Baseline to Week 168
|
-31.9 ug/mg
Standard Deviation 31.20
|
-38.3 ug/mg
Standard Deviation 47.43
|
-28.5 ug/mg
Standard Deviation 35.14
|
-39.3 ug/mg
Standard Deviation 47.39
|
-33.7 ug/mg
Standard Deviation 40.06
|
SECONDARY outcome
Timeframe: Baseline to week 168Population: MPP- modified per-protocol population, define as the ITT(intent to treat) after removing patients who had orthosurgery in first 120 weeks or \<96 doses in first 120 weeks
Efficacy was assessed by changes from baseline in urine keratan sulfate (normalized to urine creatinine.)
Outcome measures
| Measure |
PBO-QOW
n=20 Participants
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
|
PBO-QW
n=19 Participants
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
|
QOW-QOW
n=42 Participants
Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
|
QW-QW
n=43 Participants
Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
|
Total
n=124 Participants
All treatment groups
|
|---|---|---|---|---|---|
|
Change From Baseline in Urine Keratan Sulfate - MPP
Percent Change from Baseline to Week 72
|
-51.7 ug/mg
Standard Deviation 19.34
|
-58.8 ug/mg
Standard Deviation 14.60
|
-56.9 ug/mg
Standard Deviation 13.55
|
-53.7 ug/mg
Standard Deviation 17.87
|
-55.3 ug/mg
Standard Deviation 16.21
|
|
Change From Baseline in Urine Keratan Sulfate - MPP
Baseline
|
21.2 ug/mg
Standard Deviation 15.55
|
27.5 ug/mg
Standard Deviation 15.24
|
27.2 ug/mg
Standard Deviation 22.90
|
24.9 ug/mg
Standard Deviation 13.13
|
25.5 ug/mg
Standard Deviation 17.61
|
|
Change From Baseline in Urine Keratan Sulfate - MPP
Percent Change from Baseline to Week 24
|
1.2 ug/mg
Standard Deviation 24.34
|
-12.9 ug/mg
Standard Deviation 24.29
|
-35.5 ug/mg
Standard Deviation 22.62
|
-44.9 ug/mg
Standard Deviation 19.60
|
-29.7 ug/mg
Standard Deviation 27.52
|
|
Change From Baseline in Urine Keratan Sulfate - MPP
Percent Change from Baseline to Week 120
|
-58.3 ug/mg
Standard Deviation 15.87
|
-64.2 ug/mg
Standard Deviation 16.58
|
-62.1 ug/mg
Standard Deviation 15.97
|
-61.8 ug/mg
Standard Deviation 21.28
|
-61.7 ug/mg
Standard Deviation 17.98
|
|
Change From Baseline in Urine Keratan Sulfate - MPP
Percent Change from Baseline to Week 168
|
-9.9 ug/mg
Standard Deviation 23.48
|
-41.6 ug/mg
Standard Deviation 46.05
|
-27.1 ug/mg
Standard Deviation 37.28
|
-43.0 ug/mg
Standard Deviation 34.07
|
-32.8 ug/mg
Standard Deviation 37.11
|
Adverse Events
PBO-QOW
Serious events: 17 serious events
Other events: 29 other events
Deaths: 0 deaths
PBO-QW
Serious events: 15 serious events
Other events: 29 other events
Deaths: 0 deaths
QOW-QOW
Serious events: 26 serious events
Other events: 59 other events
Deaths: 1 deaths
QW-QW
Serious events: 31 serious events
Other events: 56 other events
Deaths: 0 deaths
Total
Serious events: 89 serious events
Other events: 173 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
PBO-QOW
n=29 participants at risk
PBO-QOW
|
PBO-QW
n=29 participants at risk
PBO-QW
|
QOW-QOW
n=59 participants at risk
QOW-QOW
|
QW-QW
n=56 participants at risk
QW-QW
|
Total
n=173 participants at risk
Total
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Congenital, familial and genetic disorders
Congenital osteodystrophy
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 2 • Study Period
|
0.58%
1/173 • Number of events 2 • Study Period
|
|
Congenital, familial and genetic disorders
Developmental hip dysplasia
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
1.7%
3/173 • Number of events 3 • Study Period
|
|
Ear and labyrinth disorders
Deafness
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Ear and labyrinth disorders
Middle ear effusion
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
1.2%
2/173 • Number of events 2 • Study Period
|
|
Eye disorders
Strabismus
|
0.00%
0/29 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/29 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/29 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
5.4%
3/56 • Number of events 5 • Study Period
|
2.3%
4/173 • Number of events 6 • Study Period
|
|
General disorders
Device dislocation
|
0.00%
0/29 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
1.7%
3/173 • Number of events 3 • Study Period
|
|
General disorders
Device occlusion
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
General disorders
Pyrexia
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Immune system disorders
Anaphylactic reaction
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
1.2%
2/173 • Number of events 2 • Study Period
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Infections and infestations
Appendicitis
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Infections and infestations
Dengue fever
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Infections and infestations
Gastroenteritis
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
3.4%
2/59 • Number of events 2 • Study Period
|
0.00%
0/56 • Study Period
|
1.7%
3/173 • Number of events 3 • Study Period
|
|
Infections and infestations
Infected cyst
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 2 • Study Period
|
0.58%
1/173 • Number of events 2 • Study Period
|
|
Infections and infestations
Influenza
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Infections and infestations
Lower respiratory tract infection
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
5.4%
3/56 • Number of events 3 • Study Period
|
2.3%
4/173 • Number of events 4 • Study Period
|
|
Infections and infestations
Mononucleosis syndrome
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Infections and infestations
Otitis media
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 3 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
1.2%
2/173 • Number of events 4 • Study Period
|
|
Infections and infestations
Otitis media chronic
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Infections and infestations
Pneumonia
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
5.4%
3/56 • Number of events 3 • Study Period
|
1.7%
3/173 • Number of events 3 • Study Period
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/29 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/29 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
3.4%
2/59 • Number of events 2 • Study Period
|
0.00%
0/56 • Study Period
|
1.2%
2/173 • Number of events 2 • Study Period
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
2.9%
5/173 • Number of events 5 • Study Period
|
|
Musculoskeletal and connective tissue disorders
Knee deformity
|
20.7%
6/29 • Number of events 8 • Study Period
|
27.6%
8/29 • Number of events 9 • Study Period
|
11.9%
7/59 • Number of events 7 • Study Period
|
14.3%
8/56 • Number of events 8 • Study Period
|
16.8%
29/173 • Number of events 32 • Study Period
|
|
Musculoskeletal and connective tissue disorders
Limb deformity
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/29 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Nervous system disorders
Cervical cord compression
|
3.4%
1/29 • Number of events 1 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
1.7%
3/173 • Number of events 3 • Study Period
|
|
Nervous system disorders
Cervical myelopathy
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Nervous system disorders
Convulsion
|
0.00%
0/29 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Nervous system disorders
Quadriplegia
|
0.00%
0/29 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Nervous system disorders
Spinal cord compression
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
5.4%
3/56 • Number of events 3 • Study Period
|
2.3%
4/173 • Number of events 4 • Study Period
|
|
Nervous system disorders
Spinal cord ischaemia
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Pregnancy, puerperium and perinatal conditions
Blighted ovum
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Psychiatric disorders
Somatoform disorder
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 2 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 2 • Study Period
|
|
Renal and urinary disorders
Haematuria
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
1.2%
2/173 • Number of events 2 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/29 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
1.2%
2/173 • Number of events 2 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
1.2%
2/173 • Number of events 2 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal disorder
|
0.00%
0/29 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Social circumstances
Child abuse
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Surgical and medical procedures
Central venous catheterisation
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
5.1%
3/59 • Number of events 3 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
2.9%
5/173 • Number of events 5 • Study Period
|
|
Surgical and medical procedures
Epiphyseal stapling
|
0.00%
0/29 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Surgical and medical procedures
Knee operation
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Surgical and medical procedures
Medical device implantation
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
1.2%
2/173 • Number of events 2 • Study Period
|
|
Surgical and medical procedures
Medical device removal
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
7.1%
4/56 • Number of events 4 • Study Period
|
2.9%
5/173 • Number of events 5 • Study Period
|
|
Surgical and medical procedures
Spinal decompression
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
0.58%
1/173 • Number of events 1 • Study Period
|
|
Vascular disorders
Poor venous access
|
0.00%
0/29 • Study Period
|
6.9%
2/29 • Number of events 2 • Study Period
|
8.5%
5/59 • Number of events 5 • Study Period
|
8.9%
5/56 • Number of events 5 • Study Period
|
6.9%
12/173 • Number of events 12 • Study Period
|
Other adverse events
| Measure |
PBO-QOW
n=29 participants at risk
PBO-QOW
|
PBO-QW
n=29 participants at risk
PBO-QW
|
QOW-QOW
n=59 participants at risk
QOW-QOW
|
QW-QW
n=56 participants at risk
QW-QW
|
Total
n=173 participants at risk
Total
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
10.3%
3/29 • Number of events 4 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
2.3%
4/173 • Number of events 5 • Study Period
|
|
Cardiac disorders
Aortic valve disease
|
3.4%
1/29 • Number of events 1 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
8.5%
5/59 • Number of events 5 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
5.2%
9/173 • Number of events 9 • Study Period
|
|
Cardiac disorders
Aortic valve incompetence
|
3.4%
1/29 • Number of events 1 • Study Period
|
10.3%
3/29 • Number of events 3 • Study Period
|
13.6%
8/59 • Number of events 8 • Study Period
|
7.1%
4/56 • Number of events 4 • Study Period
|
9.2%
16/173 • Number of events 16 • Study Period
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
7.1%
4/56 • Number of events 4 • Study Period
|
2.9%
5/173 • Number of events 5 • Study Period
|
|
Cardiac disorders
Mitral valve disease
|
3.4%
1/29 • Number of events 1 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
10.2%
6/59 • Number of events 6 • Study Period
|
5.4%
3/56 • Number of events 4 • Study Period
|
6.4%
11/173 • Number of events 12 • Study Period
|
|
Cardiac disorders
Mitral valve incompetence
|
13.8%
4/29 • Number of events 4 • Study Period
|
20.7%
6/29 • Number of events 6 • Study Period
|
20.3%
12/59 • Number of events 12 • Study Period
|
7.1%
4/56 • Number of events 5 • Study Period
|
15.0%
26/173 • Number of events 27 • Study Period
|
|
Cardiac disorders
Palpitations
|
3.4%
1/29 • Number of events 1 • Study Period
|
6.9%
2/29 • Number of events 4 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
3.5%
6/173 • Number of events 8 • Study Period
|
|
Cardiac disorders
Pulmonary valve incompetence
|
6.9%
2/29 • Number of events 2 • Study Period
|
10.3%
3/29 • Number of events 3 • Study Period
|
3.4%
2/59 • Number of events 2 • Study Period
|
8.9%
5/56 • Number of events 5 • Study Period
|
6.9%
12/173 • Number of events 12 • Study Period
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
5.1%
3/59 • Number of events 3 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
2.3%
4/173 • Number of events 4 • Study Period
|
|
Cardiac disorders
Sinus tachycardia
|
3.4%
1/29 • Number of events 1 • Study Period
|
10.3%
3/29 • Number of events 4 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
1.8%
1/56 • Number of events 11 • Study Period
|
3.5%
6/173 • Number of events 17 • Study Period
|
|
Cardiac disorders
Tachycardia
|
27.6%
8/29 • Number of events 14 • Study Period
|
13.8%
4/29 • Number of events 15 • Study Period
|
13.6%
8/59 • Number of events 31 • Study Period
|
19.6%
11/56 • Number of events 29 • Study Period
|
17.9%
31/173 • Number of events 89 • Study Period
|
|
Cardiac disorders
Tricuspid valve incompetence
|
20.7%
6/29 • Number of events 6 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
18.6%
11/59 • Number of events 12 • Study Period
|
12.5%
7/56 • Number of events 8 • Study Period
|
14.5%
25/173 • Number of events 27 • Study Period
|
|
Ear and labyrinth disorders
Ear discomfort
|
6.9%
2/29 • Number of events 3 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
3.6%
2/56 • Number of events 6 • Study Period
|
2.9%
5/173 • Number of events 10 • Study Period
|
|
Ear and labyrinth disorders
Ear pain
|
34.5%
10/29 • Number of events 16 • Study Period
|
24.1%
7/29 • Number of events 8 • Study Period
|
32.2%
19/59 • Number of events 42 • Study Period
|
33.9%
19/56 • Number of events 26 • Study Period
|
31.8%
55/173 • Number of events 92 • Study Period
|
|
Ear and labyrinth disorders
Hypoacusis
|
6.9%
2/29 • Number of events 3 • Study Period
|
0.00%
0/29 • Study Period
|
5.1%
3/59 • Number of events 3 • Study Period
|
5.4%
3/56 • Number of events 4 • Study Period
|
4.6%
8/173 • Number of events 10 • Study Period
|
|
Ear and labyrinth disorders
Middle ear effusion
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
2.9%
5/173 • Number of events 5 • Study Period
|
|
Ear and labyrinth disorders
Motion sickness
|
3.4%
1/29 • Number of events 1 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/59 • Study Period
|
5.4%
3/56 • Number of events 3 • Study Period
|
2.9%
5/173 • Number of events 5 • Study Period
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
5.4%
3/56 • Number of events 6 • Study Period
|
1.7%
3/173 • Number of events 6 • Study Period
|
|
Ear and labyrinth disorders
Vertigo
|
3.4%
1/29 • Number of events 4 • Study Period
|
6.9%
2/29 • Number of events 2 • Study Period
|
5.1%
3/59 • Number of events 7 • Study Period
|
5.4%
3/56 • Number of events 4 • Study Period
|
5.2%
9/173 • Number of events 17 • Study Period
|
|
Eye disorders
Astigmatism
|
0.00%
0/29 • Study Period
|
10.3%
3/29 • Number of events 3 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
2.3%
4/173 • Number of events 4 • Study Period
|
|
Eye disorders
Conjunctivitis
|
6.9%
2/29 • Number of events 2 • Study Period
|
6.9%
2/29 • Number of events 2 • Study Period
|
10.2%
6/59 • Number of events 9 • Study Period
|
14.3%
8/56 • Number of events 9 • Study Period
|
10.4%
18/173 • Number of events 22 • Study Period
|
|
Eye disorders
Corneal opacity
|
10.3%
3/29 • Number of events 3 • Study Period
|
17.2%
5/29 • Number of events 5 • Study Period
|
8.5%
5/59 • Number of events 5 • Study Period
|
21.4%
12/56 • Number of events 13 • Study Period
|
14.5%
25/173 • Number of events 26 • Study Period
|
|
Eye disorders
Glaucoma
|
0.00%
0/29 • Study Period
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
1.2%
2/173 • Number of events 2 • Study Period
|
|
Eye disorders
Myopia
|
0.00%
0/29 • Study Period
|
6.9%
2/29 • Number of events 2 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
2.3%
4/173 • Number of events 4 • Study Period
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/29 • Study Period
|
6.9%
2/29 • Number of events 2 • Study Period
|
5.1%
3/59 • Number of events 4 • Study Period
|
3.6%
2/56 • Number of events 3 • Study Period
|
4.0%
7/173 • Number of events 9 • Study Period
|
|
Eye disorders
Visual impairment
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
5.4%
3/56 • Number of events 5 • Study Period
|
1.7%
3/173 • Number of events 5 • Study Period
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.3%
3/29 • Number of events 6 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
8.5%
5/59 • Number of events 8 • Study Period
|
12.5%
7/56 • Number of events 18 • Study Period
|
9.2%
16/173 • Number of events 33 • Study Period
|
|
Gastrointestinal disorders
Abdominal distension
|
10.3%
3/29 • Number of events 19 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
3.6%
2/56 • Number of events 5 • Study Period
|
2.9%
5/173 • Number of events 24 • Study Period
|
|
Gastrointestinal disorders
Abdominal pain
|
41.4%
12/29 • Number of events 19 • Study Period
|
20.7%
6/29 • Number of events 8 • Study Period
|
37.3%
22/59 • Number of events 59 • Study Period
|
42.9%
24/56 • Number of events 60 • Study Period
|
37.0%
64/173 • Number of events 146 • Study Period
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/29 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
5.1%
3/59 • Number of events 3 • Study Period
|
0.00%
0/56 • Study Period
|
2.3%
4/173 • Number of events 4 • Study Period
|
|
Gastrointestinal disorders
Abdominal pain upper
|
27.6%
8/29 • Number of events 15 • Study Period
|
31.0%
9/29 • Number of events 11 • Study Period
|
15.3%
9/59 • Number of events 16 • Study Period
|
32.1%
18/56 • Number of events 72 • Study Period
|
25.4%
44/173 • Number of events 114 • Study Period
|
|
Gastrointestinal disorders
Anal pruritus
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
1.7%
3/173 • Number of events 3 • Study Period
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/29 • Study Period
|
10.3%
3/29 • Number of events 3 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
1.7%
3/173 • Number of events 3 • Study Period
|
|
Gastrointestinal disorders
Constipation
|
13.8%
4/29 • Number of events 5 • Study Period
|
13.8%
4/29 • Number of events 4 • Study Period
|
11.9%
7/59 • Number of events 7 • Study Period
|
14.3%
8/56 • Number of events 9 • Study Period
|
13.3%
23/173 • Number of events 25 • Study Period
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/29 • Study Period
|
10.3%
3/29 • Number of events 3 • Study Period
|
6.8%
4/59 • Number of events 4 • Study Period
|
5.4%
3/56 • Number of events 4 • Study Period
|
5.8%
10/173 • Number of events 11 • Study Period
|
|
Gastrointestinal disorders
Diarrhoea
|
37.9%
11/29 • Number of events 26 • Study Period
|
37.9%
11/29 • Number of events 27 • Study Period
|
42.4%
25/59 • Number of events 71 • Study Period
|
41.1%
23/56 • Number of events 43 • Study Period
|
40.5%
70/173 • Number of events 167 • Study Period
|
|
Gastrointestinal disorders
Dyspepsia
|
10.3%
3/29 • Number of events 26 • Study Period
|
17.2%
5/29 • Number of events 5 • Study Period
|
5.1%
3/59 • Number of events 5 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
7.5%
13/173 • Number of events 38 • Study Period
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
5.1%
3/59 • Number of events 3 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
2.3%
4/173 • Number of events 4 • Study Period
|
|
Gastrointestinal disorders
Flatulence
|
6.9%
2/29 • Number of events 6 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
3.4%
2/59 • Number of events 2 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
3.5%
6/173 • Number of events 10 • Study Period
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.4%
1/29 • Number of events 1 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
3.4%
2/59 • Number of events 3 • Study Period
|
5.4%
3/56 • Number of events 4 • Study Period
|
4.0%
7/173 • Number of events 9 • Study Period
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
1.7%
3/173 • Number of events 3 • Study Period
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.9%
2/29 • Number of events 3 • Study Period
|
0.00%
0/29 • Study Period
|
3.4%
2/59 • Number of events 3 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
2.9%
5/173 • Number of events 7 • Study Period
|
|
Gastrointestinal disorders
Nausea
|
51.7%
15/29 • Number of events 34 • Study Period
|
34.5%
10/29 • Number of events 18 • Study Period
|
44.1%
26/59 • Number of events 65 • Study Period
|
50.0%
28/56 • Number of events 91 • Study Period
|
45.7%
79/173 • Number of events 208 • Study Period
|
|
Gastrointestinal disorders
Proctalgia
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
1.2%
2/173 • Number of events 2 • Study Period
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/29 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
5.1%
3/59 • Number of events 3 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
2.9%
5/173 • Number of events 5 • Study Period
|
|
Gastrointestinal disorders
Toothache
|
10.3%
3/29 • Number of events 4 • Study Period
|
10.3%
3/29 • Number of events 5 • Study Period
|
13.6%
8/59 • Number of events 14 • Study Period
|
7.1%
4/56 • Number of events 4 • Study Period
|
10.4%
18/173 • Number of events 27 • Study Period
|
|
Gastrointestinal disorders
Vomiting
|
69.0%
20/29 • Number of events 105 • Study Period
|
58.6%
17/29 • Number of events 62 • Study Period
|
66.1%
39/59 • Number of events 134 • Study Period
|
67.9%
38/56 • Number of events 160 • Study Period
|
65.9%
114/173 • Number of events 461 • Study Period
|
|
General disorders
Asthenia
|
3.4%
1/29 • Number of events 1 • Study Period
|
6.9%
2/29 • Number of events 2 • Study Period
|
1.7%
1/59 • Number of events 2 • Study Period
|
7.1%
4/56 • Number of events 5 • Study Period
|
4.6%
8/173 • Number of events 10 • Study Period
|
|
General disorders
Catheter site pain
|
6.9%
2/29 • Number of events 6 • Study Period
|
0.00%
0/29 • Study Period
|
10.2%
6/59 • Number of events 6 • Study Period
|
8.9%
5/56 • Number of events 12 • Study Period
|
7.5%
13/173 • Number of events 24 • Study Period
|
|
General disorders
Chest discomfort
|
10.3%
3/29 • Number of events 4 • Study Period
|
6.9%
2/29 • Number of events 3 • Study Period
|
3.4%
2/59 • Number of events 2 • Study Period
|
5.4%
3/56 • Number of events 3 • Study Period
|
5.8%
10/173 • Number of events 12 • Study Period
|
|
General disorders
Chest pain
|
3.4%
1/29 • Number of events 1 • Study Period
|
6.9%
2/29 • Number of events 2 • Study Period
|
5.1%
3/59 • Number of events 5 • Study Period
|
7.1%
4/56 • Number of events 4 • Study Period
|
5.8%
10/173 • Number of events 12 • Study Period
|
|
General disorders
Chills
|
13.8%
4/29 • Number of events 4 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
13.6%
8/59 • Number of events 10 • Study Period
|
16.1%
9/56 • Number of events 14 • Study Period
|
12.7%
22/173 • Number of events 29 • Study Period
|
|
General disorders
Device dislocation
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
5.1%
3/59 • Number of events 4 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
3.5%
6/173 • Number of events 7 • Study Period
|
|
General disorders
Device occlusion
|
3.4%
1/29 • Number of events 1 • Study Period
|
3.4%
1/29 • Number of events 3 • Study Period
|
3.4%
2/59 • Number of events 2 • Study Period
|
7.1%
4/56 • Number of events 6 • Study Period
|
4.6%
8/173 • Number of events 12 • Study Period
|
|
General disorders
Effusion
|
0.00%
0/29 • Study Period
|
6.9%
2/29 • Number of events 2 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
1.8%
1/56 • Number of events 2 • Study Period
|
2.3%
4/173 • Number of events 5 • Study Period
|
|
General disorders
Extravasation
|
0.00%
0/29 • Study Period
|
10.3%
3/29 • Number of events 3 • Study Period
|
5.1%
3/59 • Number of events 6 • Study Period
|
8.9%
5/56 • Number of events 5 • Study Period
|
6.4%
11/173 • Number of events 14 • Study Period
|
|
General disorders
Fatigue
|
34.5%
10/29 • Number of events 17 • Study Period
|
44.8%
13/29 • Number of events 45 • Study Period
|
27.1%
16/59 • Number of events 32 • Study Period
|
33.9%
19/56 • Number of events 50 • Study Period
|
33.5%
58/173 • Number of events 144 • Study Period
|
|
General disorders
Feeling hot
|
0.00%
0/29 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
6.8%
4/59 • Number of events 4 • Study Period
|
3.6%
2/56 • Number of events 3 • Study Period
|
4.0%
7/173 • Number of events 8 • Study Period
|
|
General disorders
Gait disturbance
|
0.00%
0/29 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
5.1%
3/59 • Number of events 4 • Study Period
|
8.9%
5/56 • Number of events 5 • Study Period
|
5.2%
9/173 • Number of events 10 • Study Period
|
|
General disorders
Hyperthermia
|
0.00%
0/29 • Study Period
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
1.7%
3/173 • Number of events 3 • Study Period
|
|
General disorders
Influenza like illness
|
10.3%
3/29 • Number of events 3 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
5.4%
3/56 • Number of events 4 • Study Period
|
4.6%
8/173 • Number of events 9 • Study Period
|
|
General disorders
Infusion site extravasation
|
10.3%
3/29 • Number of events 4 • Study Period
|
3.4%
1/29 • Number of events 2 • Study Period
|
15.3%
9/59 • Number of events 12 • Study Period
|
7.1%
4/56 • Number of events 4 • Study Period
|
9.8%
17/173 • Number of events 22 • Study Period
|
|
General disorders
Infusion site pain
|
6.9%
2/29 • Number of events 2 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
10.2%
6/59 • Number of events 8 • Study Period
|
7.1%
4/56 • Number of events 6 • Study Period
|
7.5%
13/173 • Number of events 17 • Study Period
|
|
General disorders
Infusion site rash
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
3.4%
2/59 • Number of events 2 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
2.9%
5/173 • Number of events 5 • Study Period
|
|
General disorders
Infusion site swelling
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
5.1%
3/59 • Number of events 3 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
3.5%
6/173 • Number of events 6 • Study Period
|
|
General disorders
Irritability
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
5.4%
3/56 • Number of events 5 • Study Period
|
1.7%
3/173 • Number of events 5 • Study Period
|
|
General disorders
Local swelling
|
10.3%
3/29 • Number of events 7 • Study Period
|
0.00%
0/29 • Study Period
|
8.5%
5/59 • Number of events 5 • Study Period
|
7.1%
4/56 • Number of events 9 • Study Period
|
6.9%
12/173 • Number of events 21 • Study Period
|
|
General disorders
Malaise
|
6.9%
2/29 • Number of events 2 • Study Period
|
10.3%
3/29 • Number of events 5 • Study Period
|
10.2%
6/59 • Number of events 7 • Study Period
|
5.4%
3/56 • Number of events 5 • Study Period
|
8.1%
14/173 • Number of events 19 • Study Period
|
|
General disorders
Medical device complication
|
6.9%
2/29 • Number of events 2 • Study Period
|
3.4%
1/29 • Number of events 3 • Study Period
|
8.5%
5/59 • Number of events 6 • Study Period
|
8.9%
5/56 • Number of events 8 • Study Period
|
7.5%
13/173 • Number of events 19 • Study Period
|
|
General disorders
Non-cardiac chest pain
|
3.4%
1/29 • Number of events 1 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
6.8%
4/59 • Number of events 4 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
4.6%
8/173 • Number of events 8 • Study Period
|
|
General disorders
Oedema
|
0.00%
0/29 • Study Period
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
1.2%
2/173 • Number of events 2 • Study Period
|
|
General disorders
Oedema peripheral
|
3.4%
1/29 • Number of events 4 • Study Period
|
0.00%
0/29 • Study Period
|
6.8%
4/59 • Number of events 4 • Study Period
|
5.4%
3/56 • Number of events 4 • Study Period
|
4.6%
8/173 • Number of events 12 • Study Period
|
|
General disorders
Pain
|
17.2%
5/29 • Number of events 6 • Study Period
|
3.4%
1/29 • Number of events 3 • Study Period
|
10.2%
6/59 • Number of events 8 • Study Period
|
8.9%
5/56 • Number of events 7 • Study Period
|
9.8%
17/173 • Number of events 24 • Study Period
|
|
General disorders
Puncture site pain
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
6.8%
4/59 • Number of events 4 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
3.5%
6/173 • Number of events 6 • Study Period
|
|
General disorders
Pyrexia
|
75.9%
22/29 • Number of events 91 • Study Period
|
65.5%
19/29 • Number of events 62 • Study Period
|
64.4%
38/59 • Number of events 113 • Study Period
|
69.6%
39/56 • Number of events 231 • Study Period
|
68.2%
118/173 • Number of events 497 • Study Period
|
|
Immune system disorders
Hypersensitivity
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
8.5%
5/59 • Number of events 8 • Study Period
|
5.4%
3/56 • Number of events 3 • Study Period
|
5.2%
9/173 • Number of events 12 • Study Period
|
|
Immune system disorders
Seasonal allergy
|
6.9%
2/29 • Number of events 2 • Study Period
|
6.9%
2/29 • Number of events 4 • Study Period
|
6.8%
4/59 • Number of events 6 • Study Period
|
3.6%
2/56 • Number of events 3 • Study Period
|
5.8%
10/173 • Number of events 15 • Study Period
|
|
Infections and infestations
Bronchitis
|
17.2%
5/29 • Number of events 7 • Study Period
|
10.3%
3/29 • Number of events 4 • Study Period
|
11.9%
7/59 • Number of events 8 • Study Period
|
10.7%
6/56 • Number of events 8 • Study Period
|
12.1%
21/173 • Number of events 27 • Study Period
|
|
Infections and infestations
Cellulitis
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
1.2%
2/173 • Number of events 2 • Study Period
|
|
Infections and infestations
Ear infection
|
24.1%
7/29 • Number of events 9 • Study Period
|
10.3%
3/29 • Number of events 3 • Study Period
|
8.5%
5/59 • Number of events 13 • Study Period
|
28.6%
16/56 • Number of events 42 • Study Period
|
17.9%
31/173 • Number of events 67 • Study Period
|
|
Infections and infestations
Fungal infection
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
3.4%
2/59 • Number of events 2 • Study Period
|
5.4%
3/56 • Number of events 3 • Study Period
|
4.0%
7/173 • Number of events 7 • Study Period
|
|
Infections and infestations
Furuncle
|
6.9%
2/29 • Number of events 4 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 3 • Study Period
|
1.7%
3/173 • Number of events 7 • Study Period
|
|
Infections and infestations
Gastroenteritis
|
17.2%
5/29 • Number of events 9 • Study Period
|
31.0%
9/29 • Number of events 13 • Study Period
|
40.7%
24/59 • Number of events 36 • Study Period
|
30.4%
17/56 • Number of events 20 • Study Period
|
31.8%
55/173 • Number of events 78 • Study Period
|
|
Infections and infestations
Gastroenteritis viral
|
6.9%
2/29 • Number of events 2 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
3.4%
2/59 • Number of events 2 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
4.0%
7/173 • Number of events 7 • Study Period
|
|
Infections and infestations
Gingivitis
|
0.00%
0/29 • Study Period
|
6.9%
2/29 • Number of events 3 • Study Period
|
5.1%
3/59 • Number of events 3 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
4.0%
7/173 • Number of events 8 • Study Period
|
|
Infections and infestations
Hordeolum
|
3.4%
1/29 • Number of events 2 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
10.2%
6/59 • Number of events 14 • Study Period
|
0.00%
0/56 • Study Period
|
4.6%
8/173 • Number of events 17 • Study Period
|
|
Infections and infestations
Influenza
|
10.3%
3/29 • Number of events 7 • Study Period
|
17.2%
5/29 • Number of events 6 • Study Period
|
18.6%
11/59 • Number of events 24 • Study Period
|
8.9%
5/56 • Number of events 6 • Study Period
|
13.9%
24/173 • Number of events 43 • Study Period
|
|
Infections and infestations
Laryngitis
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
5.1%
3/59 • Number of events 4 • Study Period
|
0.00%
0/56 • Study Period
|
1.7%
3/173 • Number of events 4 • Study Period
|
|
Infections and infestations
Lice infestation
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 2 • Study Period
|
8.9%
5/56 • Number of events 6 • Study Period
|
3.5%
6/173 • Number of events 8 • Study Period
|
|
Infections and infestations
Lower respiratory tract infection
|
3.4%
1/29 • Number of events 2 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
3.4%
2/59 • Number of events 2 • Study Period
|
5.4%
3/56 • Number of events 3 • Study Period
|
4.0%
7/173 • Number of events 8 • Study Period
|
|
Infections and infestations
Nasopharyngitis
|
44.8%
13/29 • Number of events 34 • Study Period
|
44.8%
13/29 • Number of events 28 • Study Period
|
49.2%
29/59 • Number of events 62 • Study Period
|
50.0%
28/56 • Number of events 67 • Study Period
|
48.0%
83/173 • Number of events 191 • Study Period
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/29 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
6.8%
4/59 • Number of events 7 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
3.5%
6/173 • Number of events 9 • Study Period
|
|
Infections and infestations
Oral herpes
|
3.4%
1/29 • Number of events 2 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
6.8%
4/59 • Number of events 7 • Study Period
|
0.00%
0/56 • Study Period
|
3.5%
6/173 • Number of events 10 • Study Period
|
|
Infections and infestations
Otitis externa
|
10.3%
3/29 • Number of events 4 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
13.6%
8/59 • Number of events 15 • Study Period
|
10.7%
6/56 • Number of events 8 • Study Period
|
10.4%
18/173 • Number of events 28 • Study Period
|
|
Infections and infestations
Otitis media
|
27.6%
8/29 • Number of events 10 • Study Period
|
17.2%
5/29 • Number of events 5 • Study Period
|
18.6%
11/59 • Number of events 29 • Study Period
|
17.9%
10/56 • Number of events 18 • Study Period
|
19.7%
34/173 • Number of events 62 • Study Period
|
|
Infections and infestations
Otitis media acute
|
3.4%
1/29 • Number of events 2 • Study Period
|
6.9%
2/29 • Number of events 2 • Study Period
|
8.5%
5/59 • Number of events 11 • Study Period
|
7.1%
4/56 • Number of events 6 • Study Period
|
6.9%
12/173 • Number of events 21 • Study Period
|
|
Infections and infestations
Pharyngitis
|
31.0%
9/29 • Number of events 12 • Study Period
|
20.7%
6/29 • Number of events 7 • Study Period
|
13.6%
8/59 • Number of events 10 • Study Period
|
19.6%
11/56 • Number of events 18 • Study Period
|
19.7%
34/173 • Number of events 47 • Study Period
|
|
Infections and infestations
Rash pustular
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
1.2%
2/173 • Number of events 2 • Study Period
|
|
Infections and infestations
Respiratory tract infection viral
|
3.4%
1/29 • Number of events 1 • Study Period
|
6.9%
2/29 • Number of events 2 • Study Period
|
5.1%
3/59 • Number of events 6 • Study Period
|
5.4%
3/56 • Number of events 4 • Study Period
|
5.2%
9/173 • Number of events 13 • Study Period
|
|
Infections and infestations
Rhinitis
|
31.0%
9/29 • Number of events 21 • Study Period
|
20.7%
6/29 • Number of events 17 • Study Period
|
18.6%
11/59 • Number of events 30 • Study Period
|
16.1%
9/56 • Number of events 19 • Study Period
|
20.2%
35/173 • Number of events 87 • Study Period
|
|
Infections and infestations
Sinusitis
|
17.2%
5/29 • Number of events 7 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
6.8%
4/59 • Number of events 4 • Study Period
|
7.1%
4/56 • Number of events 6 • Study Period
|
8.1%
14/173 • Number of events 18 • Study Period
|
|
Infections and infestations
Tinea pedis
|
6.9%
2/29 • Number of events 2 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/59 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
2.9%
5/173 • Number of events 5 • Study Period
|
|
Infections and infestations
Tonsillitis
|
6.9%
2/29 • Number of events 3 • Study Period
|
6.9%
2/29 • Number of events 2 • Study Period
|
8.5%
5/59 • Number of events 8 • Study Period
|
10.7%
6/56 • Number of events 7 • Study Period
|
8.7%
15/173 • Number of events 20 • Study Period
|
|
Infections and infestations
Tooth infection
|
0.00%
0/29 • Study Period
|
6.9%
2/29 • Number of events 2 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
1.8%
1/56 • Number of events 2 • Study Period
|
2.3%
4/173 • Number of events 5 • Study Period
|
|
Infections and infestations
Upper respiratory tract infection
|
44.8%
13/29 • Number of events 53 • Study Period
|
27.6%
8/29 • Number of events 25 • Study Period
|
40.7%
24/59 • Number of events 82 • Study Period
|
42.9%
24/56 • Number of events 81 • Study Period
|
39.9%
69/173 • Number of events 241 • Study Period
|
|
Infections and infestations
Varicella
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
5.1%
3/59 • Number of events 3 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
3.5%
6/173 • Number of events 6 • Study Period
|
|
Infections and infestations
Viral infection
|
3.4%
1/29 • Number of events 3 • Study Period
|
10.3%
3/29 • Number of events 5 • Study Period
|
15.3%
9/59 • Number of events 12 • Study Period
|
8.9%
5/56 • Number of events 6 • Study Period
|
10.4%
18/173 • Number of events 26 • Study Period
|
|
Infections and infestations
Viral pharyngitis
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
1.2%
2/173 • Number of events 2 • Study Period
|
|
Infections and infestations
Viral upper respiratory tract infection
|
20.7%
6/29 • Number of events 12 • Study Period
|
0.00%
0/29 • Study Period
|
8.5%
5/59 • Number of events 9 • Study Period
|
8.9%
5/56 • Number of events 10 • Study Period
|
9.2%
16/173 • Number of events 31 • Study Period
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/29 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
3.4%
2/59 • Number of events 2 • Study Period
|
10.7%
6/56 • Number of events 7 • Study Period
|
5.2%
9/173 • Number of events 10 • Study Period
|
|
Injury, poisoning and procedural complications
Contusion
|
10.3%
3/29 • Number of events 3 • Study Period
|
0.00%
0/29 • Study Period
|
3.4%
2/59 • Number of events 3 • Study Period
|
3.6%
2/56 • Number of events 3 • Study Period
|
4.0%
7/173 • Number of events 9 • Study Period
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
6.8%
4/59 • Number of events 5 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
3.5%
6/173 • Number of events 7 • Study Period
|
|
Injury, poisoning and procedural complications
Fall
|
13.8%
4/29 • Number of events 5 • Study Period
|
10.3%
3/29 • Number of events 4 • Study Period
|
20.3%
12/59 • Number of events 20 • Study Period
|
8.9%
5/56 • Number of events 7 • Study Period
|
13.9%
24/173 • Number of events 36 • Study Period
|
|
Injury, poisoning and procedural complications
Head injury
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
6.8%
4/59 • Number of events 8 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
4.0%
7/173 • Number of events 11 • Study Period
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
10.3%
3/29 • Number of events 5 • Study Period
|
0.00%
0/29 • Study Period
|
3.4%
2/59 • Number of events 4 • Study Period
|
3.6%
2/56 • Number of events 3 • Study Period
|
4.0%
7/173 • Number of events 12 • Study Period
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
6.8%
4/59 • Number of events 5 • Study Period
|
0.00%
0/56 • Study Period
|
2.3%
4/173 • Number of events 5 • Study Period
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
6.8%
4/59 • Number of events 4 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
3.5%
6/173 • Number of events 6 • Study Period
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
6.9%
2/29 • Number of events 2 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
2.9%
5/173 • Number of events 5 • Study Period
|
|
Injury, poisoning and procedural complications
Limb injury
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
5.1%
3/59 • Number of events 3 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
3.5%
6/173 • Number of events 6 • Study Period
|
|
Injury, poisoning and procedural complications
Procedural pain
|
10.3%
3/29 • Number of events 9 • Study Period
|
6.9%
2/29 • Number of events 2 • Study Period
|
10.2%
6/59 • Number of events 7 • Study Period
|
12.5%
7/56 • Number of events 9 • Study Period
|
10.4%
18/173 • Number of events 27 • Study Period
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
1.7%
3/173 • Number of events 3 • Study Period
|
|
Investigations
Blood cholesterol increased
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
2.3%
4/173 • Number of events 4 • Study Period
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/29 • Study Period
|
6.9%
2/29 • Number of events 4 • Study Period
|
5.1%
3/59 • Number of events 9 • Study Period
|
5.4%
3/56 • Number of events 4 • Study Period
|
4.6%
8/173 • Number of events 17 • Study Period
|
|
Investigations
Blood pressure increased
|
6.9%
2/29 • Number of events 6 • Study Period
|
0.00%
0/29 • Study Period
|
5.1%
3/59 • Number of events 3 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
3.5%
6/173 • Number of events 10 • Study Period
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/29 • Study Period
|
6.9%
2/29 • Number of events 7 • Study Period
|
5.1%
3/59 • Number of events 28 • Study Period
|
1.8%
1/56 • Number of events 2 • Study Period
|
3.5%
6/173 • Number of events 37 • Study Period
|
|
Investigations
Blood urine present
|
6.9%
2/29 • Number of events 5 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
0.00%
0/56 • Study Period
|
1.7%
3/173 • Number of events 6 • Study Period
|
|
Investigations
Heart rate decreased
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
1.2%
2/173 • Number of events 2 • Study Period
|
|
Investigations
Heart rate increased
|
6.9%
2/29 • Number of events 3 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
6.8%
4/59 • Number of events 4 • Study Period
|
12.5%
7/56 • Number of events 13 • Study Period
|
8.1%
14/173 • Number of events 21 • Study Period
|
|
Investigations
Oxygen saturation decreased
|
20.7%
6/29 • Number of events 17 • Study Period
|
10.3%
3/29 • Number of events 15 • Study Period
|
15.3%
9/59 • Number of events 16 • Study Period
|
17.9%
10/56 • Number of events 26 • Study Period
|
16.2%
28/173 • Number of events 74 • Study Period
|
|
Investigations
Respiratory rate increased
|
13.8%
4/29 • Number of events 5 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
3.4%
2/59 • Number of events 2 • Study Period
|
5.4%
3/56 • Number of events 3 • Study Period
|
5.8%
10/173 • Number of events 11 • Study Period
|
|
Investigations
Vital capacity decreased
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
5.1%
3/59 • Number of events 3 • Study Period
|
0.00%
0/56 • Study Period
|
2.3%
4/173 • Number of events 4 • Study Period
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.4%
1/29 • Number of events 1 • Study Period
|
6.9%
2/29 • Number of events 3 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
8.9%
5/56 • Number of events 5 • Study Period
|
5.2%
9/173 • Number of events 10 • Study Period
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
69.0%
20/29 • Number of events 90 • Study Period
|
55.2%
16/29 • Number of events 57 • Study Period
|
67.8%
40/59 • Number of events 93 • Study Period
|
51.8%
29/56 • Number of events 94 • Study Period
|
60.7%
105/173 • Number of events 334 • Study Period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
34.5%
10/29 • Number of events 17 • Study Period
|
13.8%
4/29 • Number of events 6 • Study Period
|
32.2%
19/59 • Number of events 45 • Study Period
|
32.1%
18/56 • Number of events 46 • Study Period
|
29.5%
51/173 • Number of events 114 • Study Period
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
3.4%
2/59 • Number of events 2 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
2.9%
5/173 • Number of events 5 • Study Period
|
|
Musculoskeletal and connective tissue disorders
Knee deformity
|
6.9%
2/29 • Number of events 2 • Study Period
|
17.2%
5/29 • Number of events 6 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
10.7%
6/56 • Number of events 6 • Study Period
|
8.1%
14/173 • Number of events 15 • Study Period
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.9%
2/29 • Number of events 2 • Study Period
|
10.3%
3/29 • Number of events 4 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
5.4%
3/56 • Number of events 4 • Study Period
|
5.2%
9/173 • Number of events 11 • Study Period
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.4%
1/29 • Number of events 3 • Study Period
|
3.4%
1/29 • Number of events 2 • Study Period
|
8.5%
5/59 • Number of events 5 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
5.2%
9/173 • Number of events 12 • Study Period
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
24.1%
7/29 • Number of events 14 • Study Period
|
13.8%
4/29 • Number of events 9 • Study Period
|
16.9%
10/59 • Number of events 14 • Study Period
|
16.1%
9/56 • Number of events 20 • Study Period
|
17.3%
30/173 • Number of events 57 • Study Period
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.9%
2/29 • Number of events 2 • Study Period
|
3.4%
1/29 • Number of events 2 • Study Period
|
5.1%
3/59 • Number of events 4 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
4.0%
7/173 • Number of events 9 • Study Period
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
24.1%
7/29 • Number of events 11 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
5.1%
3/59 • Number of events 3 • Study Period
|
8.9%
5/56 • Number of events 9 • Study Period
|
9.2%
16/173 • Number of events 24 • Study Period
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
31.0%
9/29 • Number of events 9 • Study Period
|
10.3%
3/29 • Number of events 3 • Study Period
|
15.3%
9/59 • Number of events 14 • Study Period
|
17.9%
10/56 • Number of events 24 • Study Period
|
17.9%
31/173 • Number of events 50 • Study Period
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
6.9%
2/29 • Number of events 2 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
6.8%
4/59 • Number of events 4 • Study Period
|
0.00%
0/56 • Study Period
|
4.0%
7/173 • Number of events 7 • Study Period
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
55.2%
16/29 • Number of events 54 • Study Period
|
41.4%
12/29 • Number of events 25 • Study Period
|
45.8%
27/59 • Number of events 80 • Study Period
|
55.4%
31/56 • Number of events 102 • Study Period
|
49.7%
86/173 • Number of events 261 • Study Period
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
10.3%
3/29 • Number of events 3 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
8.9%
5/56 • Number of events 6 • Study Period
|
4.6%
8/173 • Number of events 9 • Study Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/29 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
5.1%
3/59 • Number of events 3 • Study Period
|
0.00%
0/56 • Study Period
|
2.3%
4/173 • Number of events 4 • Study Period
|
|
Nervous system disorders
Cervical cord compression
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
1.2%
2/173 • Number of events 2 • Study Period
|
|
Nervous system disorders
Dizziness
|
17.2%
5/29 • Number of events 6 • Study Period
|
20.7%
6/29 • Number of events 6 • Study Period
|
13.6%
8/59 • Number of events 20 • Study Period
|
21.4%
12/56 • Number of events 30 • Study Period
|
17.9%
31/173 • Number of events 62 • Study Period
|
|
Nervous system disorders
Headache
|
79.3%
23/29 • Number of events 102 • Study Period
|
55.2%
16/29 • Number of events 67 • Study Period
|
66.1%
39/59 • Number of events 232 • Study Period
|
64.3%
36/56 • Number of events 271 • Study Period
|
65.9%
114/173 • Number of events 672 • Study Period
|
|
Nervous system disorders
Hyperreflexia
|
6.9%
2/29 • Number of events 3 • Study Period
|
10.3%
3/29 • Number of events 4 • Study Period
|
1.7%
1/59 • Number of events 2 • Study Period
|
0.00%
0/56 • Study Period
|
3.5%
6/173 • Number of events 9 • Study Period
|
|
Nervous system disorders
Hypoaesthesia
|
3.4%
1/29 • Number of events 1 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
6.8%
4/59 • Number of events 5 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
4.0%
7/173 • Number of events 8 • Study Period
|
|
Nervous system disorders
Lethargy
|
3.4%
1/29 • Number of events 1 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
5.1%
3/59 • Number of events 3 • Study Period
|
5.4%
3/56 • Number of events 4 • Study Period
|
4.6%
8/173 • Number of events 9 • Study Period
|
|
Nervous system disorders
Paraesthesia
|
3.4%
1/29 • Number of events 1 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
3.4%
2/59 • Number of events 2 • Study Period
|
12.5%
7/56 • Number of events 18 • Study Period
|
6.4%
11/173 • Number of events 22 • Study Period
|
|
Nervous system disorders
Somnolence
|
6.9%
2/29 • Number of events 28 • Study Period
|
10.3%
3/29 • Number of events 3 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
7.1%
4/56 • Number of events 4 • Study Period
|
5.8%
10/173 • Number of events 36 • Study Period
|
|
Nervous system disorders
Syncope
|
0.00%
0/29 • Study Period
|
6.9%
2/29 • Number of events 9 • Study Period
|
0.00%
0/59 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
1.7%
3/173 • Number of events 10 • Study Period
|
|
Psychiatric disorders
Agitation
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
3.4%
2/59 • Number of events 2 • Study Period
|
7.1%
4/56 • Number of events 6 • Study Period
|
4.0%
7/173 • Number of events 9 • Study Period
|
|
Psychiatric disorders
Anxiety
|
10.3%
3/29 • Number of events 4 • Study Period
|
10.3%
3/29 • Number of events 4 • Study Period
|
8.5%
5/59 • Number of events 7 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
6.9%
12/173 • Number of events 16 • Study Period
|
|
Psychiatric disorders
Insomnia
|
6.9%
2/29 • Number of events 2 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
3.4%
2/59 • Number of events 3 • Study Period
|
0.00%
0/56 • Study Period
|
2.9%
5/173 • Number of events 6 • Study Period
|
|
Renal and urinary disorders
Dysuria
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
5.1%
3/59 • Number of events 3 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
4.0%
7/173 • Number of events 7 • Study Period
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 2 • Study Period
|
7.1%
4/56 • Number of events 4 • Study Period
|
2.9%
5/173 • Number of events 6 • Study Period
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
6.8%
4/59 • Number of events 4 • Study Period
|
5.4%
3/56 • Number of events 3 • Study Period
|
4.0%
7/173 • Number of events 7 • Study Period
|
|
Renal and urinary disorders
Proteinuria
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
5.1%
3/59 • Number of events 4 • Study Period
|
5.4%
3/56 • Number of events 4 • Study Period
|
4.6%
8/173 • Number of events 10 • Study Period
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
10.3%
3/29 • Number of events 11 • Study Period
|
3.4%
1/29 • Number of events 4 • Study Period
|
8.5%
5/59 • Number of events 24 • Study Period
|
5.4%
3/56 • Number of events 9 • Study Period
|
6.9%
12/173 • Number of events 48 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
3.4%
1/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
5.1%
3/59 • Number of events 3 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
2.9%
5/173 • Number of events 6 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
6.9%
2/29 • Number of events 2 • Study Period
|
6.9%
2/29 • Number of events 3 • Study Period
|
8.5%
5/59 • Number of events 12 • Study Period
|
5.4%
3/56 • Number of events 11 • Study Period
|
6.9%
12/173 • Number of events 28 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/29 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
8.5%
5/59 • Number of events 6 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
4.6%
8/173 • Number of events 9 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
72.4%
21/29 • Number of events 62 • Study Period
|
48.3%
14/29 • Number of events 49 • Study Period
|
62.7%
37/59 • Number of events 85 • Study Period
|
50.0%
28/56 • Number of events 70 • Study Period
|
57.8%
100/173 • Number of events 266 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.7%
6/29 • Number of events 8 • Study Period
|
17.2%
5/29 • Number of events 7 • Study Period
|
20.3%
12/59 • Number of events 33 • Study Period
|
19.6%
11/56 • Number of events 23 • Study Period
|
19.7%
34/173 • Number of events 71 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.3%
3/29 • Number of events 9 • Study Period
|
13.8%
4/29 • Number of events 8 • Study Period
|
8.5%
5/59 • Number of events 6 • Study Period
|
14.3%
8/56 • Number of events 19 • Study Period
|
11.6%
20/173 • Number of events 42 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
34.5%
10/29 • Number of events 21 • Study Period
|
13.8%
4/29 • Number of events 6 • Study Period
|
25.4%
15/59 • Number of events 24 • Study Period
|
28.6%
16/56 • Number of events 38 • Study Period
|
26.0%
45/173 • Number of events 89 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
10.3%
3/29 • Number of events 10 • Study Period
|
10.3%
3/29 • Number of events 3 • Study Period
|
10.2%
6/59 • Number of events 7 • Study Period
|
5.4%
3/56 • Number of events 3 • Study Period
|
8.7%
15/173 • Number of events 23 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal hypoxia
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
3.4%
2/59 • Number of events 2 • Study Period
|
5.4%
3/56 • Number of events 4 • Study Period
|
2.9%
5/173 • Number of events 6 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/29 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
5.4%
3/56 • Number of events 4 • Study Period
|
2.9%
5/173 • Number of events 6 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
44.8%
13/29 • Number of events 24 • Study Period
|
37.9%
11/29 • Number of events 16 • Study Period
|
39.0%
23/59 • Number of events 48 • Study Period
|
48.2%
27/56 • Number of events 63 • Study Period
|
42.8%
74/173 • Number of events 151 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal disorder
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
0.00%
0/56 • Study Period
|
1.2%
2/173 • Number of events 2 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
5.4%
3/56 • Number of events 5 • Study Period
|
1.7%
3/173 • Number of events 5 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.4%
1/29 • Number of events 1 • Study Period
|
10.3%
3/29 • Number of events 3 • Study Period
|
3.4%
2/59 • Number of events 2 • Study Period
|
0.00%
0/56 • Study Period
|
3.5%
6/173 • Number of events 6 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
5.1%
3/59 • Number of events 5 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
2.3%
4/173 • Number of events 6 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
1.8%
1/56 • Number of events 2 • Study Period
|
2.3%
4/173 • Number of events 5 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
10.3%
3/29 • Number of events 3 • Study Period
|
17.2%
5/29 • Number of events 7 • Study Period
|
15.3%
9/59 • Number of events 14 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
11.0%
19/173 • Number of events 26 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
17.2%
5/29 • Number of events 6 • Study Period
|
17.2%
5/29 • Number of events 10 • Study Period
|
11.9%
7/59 • Number of events 16 • Study Period
|
25.0%
14/56 • Number of events 24 • Study Period
|
17.9%
31/173 • Number of events 56 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
6.9%
2/29 • Number of events 2 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/59 • Study Period
|
5.4%
3/56 • Number of events 4 • Study Period
|
3.5%
6/173 • Number of events 7 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
3.4%
1/29 • Number of events 1 • Study Period
|
6.9%
2/29 • Number of events 2 • Study Period
|
6.8%
4/59 • Number of events 4 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
5.2%
9/173 • Number of events 9 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
6.9%
2/29 • Number of events 2 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
3.5%
6/173 • Number of events 6 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
10.3%
3/29 • Number of events 3 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
5.1%
3/59 • Number of events 6 • Study Period
|
3.6%
2/56 • Number of events 4 • Study Period
|
5.2%
9/173 • Number of events 14 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
10.3%
3/29 • Number of events 3 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/59 • Study Period
|
7.1%
4/56 • Number of events 5 • Study Period
|
4.6%
8/173 • Number of events 9 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
6.9%
2/29 • Number of events 3 • Study Period
|
6.9%
2/29 • Number of events 2 • Study Period
|
3.4%
2/59 • Number of events 3 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
4.0%
7/173 • Number of events 9 • Study Period
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
17.2%
5/29 • Number of events 10 • Study Period
|
17.2%
5/29 • Number of events 6 • Study Period
|
10.2%
6/59 • Number of events 8 • Study Period
|
7.1%
4/56 • Number of events 6 • Study Period
|
11.6%
20/173 • Number of events 30 • Study Period
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.9%
2/29 • Number of events 2 • Study Period
|
10.3%
3/29 • Number of events 3 • Study Period
|
3.4%
2/59 • Number of events 2 • Study Period
|
5.4%
3/56 • Number of events 4 • Study Period
|
5.8%
10/173 • Number of events 11 • Study Period
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
5.1%
3/59 • Number of events 6 • Study Period
|
3.6%
2/56 • Number of events 4 • Study Period
|
2.9%
5/173 • Number of events 10 • Study Period
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.4%
1/29 • Number of events 1 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
5.4%
3/56 • Number of events 4 • Study Period
|
2.9%
5/173 • Number of events 6 • Study Period
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
6.9%
2/29 • Number of events 2 • Study Period
|
0.00%
0/29 • Study Period
|
8.5%
5/59 • Number of events 5 • Study Period
|
0.00%
0/56 • Study Period
|
4.0%
7/173 • Number of events 7 • Study Period
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.3%
3/29 • Number of events 3 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
3.6%
2/56 • Number of events 3 • Study Period
|
3.5%
6/173 • Number of events 7 • Study Period
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.9%
2/29 • Number of events 2 • Study Period
|
13.8%
4/29 • Number of events 7 • Study Period
|
13.6%
8/59 • Number of events 10 • Study Period
|
1.8%
1/56 • Number of events 2 • Study Period
|
8.7%
15/173 • Number of events 21 • Study Period
|
|
Skin and subcutaneous tissue disorders
Erythema
|
20.7%
6/29 • Number of events 12 • Study Period
|
10.3%
3/29 • Number of events 4 • Study Period
|
11.9%
7/59 • Number of events 7 • Study Period
|
17.9%
10/56 • Number of events 29 • Study Period
|
15.0%
26/173 • Number of events 52 • Study Period
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.4%
1/29 • Number of events 1 • Study Period
|
13.8%
4/29 • Number of events 6 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
5.4%
3/56 • Number of events 3 • Study Period
|
5.2%
9/173 • Number of events 11 • Study Period
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
6.8%
4/59 • Number of events 4 • Study Period
|
0.00%
0/56 • Study Period
|
2.3%
4/173 • Number of events 4 • Study Period
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
24.1%
7/29 • Number of events 18 • Study Period
|
10.3%
3/29 • Number of events 6 • Study Period
|
13.6%
8/59 • Number of events 28 • Study Period
|
33.9%
19/56 • Number of events 32 • Study Period
|
21.4%
37/173 • Number of events 84 • Study Period
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.6%
8/29 • Number of events 13 • Study Period
|
27.6%
8/29 • Number of events 30 • Study Period
|
25.4%
15/59 • Number of events 61 • Study Period
|
33.9%
19/56 • Number of events 103 • Study Period
|
28.9%
50/173 • Number of events 207 • Study Period
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
6.9%
2/29 • Number of events 3 • Study Period
|
0.00%
0/29 • Study Period
|
1.7%
1/59 • Number of events 3 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
2.3%
4/173 • Number of events 7 • Study Period
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
3.4%
1/29 • Number of events 5 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
1.7%
1/59 • Number of events 1 • Study Period
|
5.4%
3/56 • Number of events 3 • Study Period
|
3.5%
6/173 • Number of events 10 • Study Period
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
5.1%
3/59 • Number of events 59 • Study Period
|
3.6%
2/56 • Number of events 28 • Study Period
|
2.9%
5/173 • Number of events 87 • Study Period
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
5.1%
3/59 • Number of events 3 • Study Period
|
0.00%
0/56 • Study Period
|
1.7%
3/173 • Number of events 3 • Study Period
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/29 • Study Period
|
0.00%
0/29 • Study Period
|
0.00%
0/59 • Study Period
|
5.4%
3/56 • Number of events 7 • Study Period
|
1.7%
3/173 • Number of events 7 • Study Period
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
6.9%
2/29 • Number of events 2 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
5.1%
3/59 • Number of events 3 • Study Period
|
5.4%
3/56 • Number of events 3 • Study Period
|
5.2%
9/173 • Number of events 9 • Study Period
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
20.7%
6/29 • Number of events 38 • Study Period
|
3.4%
1/29 • Number of events 37 • Study Period
|
18.6%
11/59 • Number of events 53 • Study Period
|
21.4%
12/56 • Number of events 33 • Study Period
|
17.3%
30/173 • Number of events 161 • Study Period
|
|
Surgical and medical procedures
Central venous catheterisation
|
3.4%
1/29 • Number of events 1 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
5.1%
3/59 • Number of events 3 • Study Period
|
1.8%
1/56 • Number of events 1 • Study Period
|
3.5%
6/173 • Number of events 6 • Study Period
|
|
Surgical and medical procedures
Tooth extraction
|
3.4%
1/29 • Number of events 1 • Study Period
|
6.9%
2/29 • Number of events 2 • Study Period
|
6.8%
4/59 • Number of events 6 • Study Period
|
0.00%
0/56 • Study Period
|
4.0%
7/173 • Number of events 9 • Study Period
|
|
Vascular disorders
Flushing
|
3.4%
1/29 • Number of events 3 • Study Period
|
6.9%
2/29 • Number of events 2 • Study Period
|
3.4%
2/59 • Number of events 2 • Study Period
|
8.9%
5/56 • Number of events 8 • Study Period
|
5.8%
10/173 • Number of events 15 • Study Period
|
|
Vascular disorders
Hot flush
|
0.00%
0/29 • Study Period
|
6.9%
2/29 • Number of events 6 • Study Period
|
5.1%
3/59 • Number of events 5 • Study Period
|
3.6%
2/56 • Number of events 2 • Study Period
|
4.0%
7/173 • Number of events 13 • Study Period
|
|
Vascular disorders
Hypertension
|
3.4%
1/29 • Number of events 1 • Study Period
|
13.8%
4/29 • Number of events 13 • Study Period
|
10.2%
6/59 • Number of events 28 • Study Period
|
10.7%
6/56 • Number of events 16 • Study Period
|
9.8%
17/173 • Number of events 58 • Study Period
|
|
Vascular disorders
Hypotension
|
6.9%
2/29 • Number of events 2 • Study Period
|
3.4%
1/29 • Number of events 1 • Study Period
|
5.1%
3/59 • Number of events 6 • Study Period
|
10.7%
6/56 • Number of events 7 • Study Period
|
6.9%
12/173 • Number of events 16 • Study Period
|
|
Vascular disorders
Pallor
|
6.9%
2/29 • Number of events 3 • Study Period
|
6.9%
2/29 • Number of events 2 • Study Period
|
3.4%
2/59 • Number of events 4 • Study Period
|
12.5%
7/56 • Number of events 21 • Study Period
|
7.5%
13/173 • Number of events 30 • Study Period
|
|
Vascular disorders
Poor venous access
|
20.7%
6/29 • Number of events 21 • Study Period
|
17.2%
5/29 • Number of events 10 • Study Period
|
10.2%
6/59 • Number of events 7 • Study Period
|
14.3%
8/56 • Number of events 16 • Study Period
|
14.5%
25/173 • Number of events 54 • Study Period
|
Additional Information
Peter Slasor/Sr Director, Biostatistics, Global Clinical Sciences
BioMarin Pharmaceutical Inc.
Phone: 415-506-6765
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place