Trial Outcomes & Findings for A Double-Blind Study to Evaluate the Efficacy and Safety of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome) (NCT NCT01275066)
NCT ID: NCT01275066
Last Updated: 2014-07-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
177 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2014-07-07
Participant Flow
Participant milestones
| Measure |
Placebo
Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
|
BMN110 2.0 mg/kg/Qow
Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
|
BMN110 2.0 mg/kg/Week
Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
59
|
58
|
|
Overall Study
Treated
|
59
|
59
|
58
|
|
Overall Study
COMPLETED
|
59
|
59
|
57
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
|
BMN110 2.0 mg/kg/Qow
Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
|
BMN110 2.0 mg/kg/Week
Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Not Diagnosed w/ Disease
|
1
|
0
|
0
|
Baseline Characteristics
A Double-Blind Study to Evaluate the Efficacy and Safety of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome)
Baseline characteristics by cohort
| Measure |
Placebo
n=59 Participants
Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
|
BMN110 2.0 mg/kg/Qow
n=59 Participants
Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
|
BMN110 2.0 mg/kg/Week
n=58 Participants
Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
15.0 years
STANDARD_DEVIATION 11.30 • n=5 Participants
|
15.3 years
STANDARD_DEVIATION 10.79 • n=7 Participants
|
13.1 years
STANDARD_DEVIATION 8.10 • n=5 Participants
|
14.5 years
STANDARD_DEVIATION 10.16 • n=4 Participants
|
|
Age, Customized
5 - 11 years
|
30 participants
n=5 Participants
|
31 participants
n=7 Participants
|
32 participants
n=5 Participants
|
93 participants
n=4 Participants
|
|
Age, Customized
12 - 18 years
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
16 participants
n=5 Participants
|
47 participants
n=4 Participants
|
|
Age, Customized
>= 19 years
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
10 participants
n=5 Participants
|
36 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 participants
n=5 Participants
|
15 participants
n=7 Participants
|
14 participants
n=5 Participants
|
40 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
44 participants
n=5 Participants
|
35 participants
n=7 Participants
|
36 participants
n=5 Participants
|
115 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
Region of Enrollment
Argentina
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Brazil
|
6 participants
n=5 Participants
|
10 participants
n=7 Participants
|
5 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Region of Enrollment
Colombia
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
Denmark
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
France
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
1 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
Korea, South
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Region of Enrollment
Netherlands
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
Portugal
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
Qatar
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Saudi Arabia
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Region of Enrollment
Taiwan
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
33 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Intention to treat (all patients receiving at least one dose of study drug). Two missing outcomes at Week 24 were imputed using method of multiple imputation.
Outcome measures
| Measure |
Placebo
n=59 Participants
Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
|
BMN110 2.0 mg/kg/Qow
n=59 Participants
Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
|
BMN110 2.0 mg/kg/Week
n=58 Participants
Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
|
|---|---|---|---|
|
Change From Baseline in Endurance as Measured by the 6-minute Walk Test
Baseline
|
211.9 meters
Standard Deviation 69.88
|
205.7 meters
Standard Deviation 81.19
|
203.9 meters
Standard Deviation 76.32
|
|
Change From Baseline in Endurance as Measured by the 6-minute Walk Test
Week 24
|
225.4 meters
Standard Deviation 83.22
|
219.9 meters
Standard Deviation 87.60
|
240.0 meters
Standard Deviation 86.61
|
|
Change From Baseline in Endurance as Measured by the 6-minute Walk Test
Change from Baseline to Week 24
|
13.5 meters
Standard Deviation 50.63
|
14.2 meters
Standard Deviation 40.82
|
36.0 meters
Standard Deviation 58.11
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Intention to treat (all patients receiving at least one dose of study drug). Two missing outcomes at Week 24 were imputed using method of multiple imputation.
Outcome measures
| Measure |
Placebo
n=59 Participants
Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
|
BMN110 2.0 mg/kg/Qow
n=59 Participants
Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
|
BMN110 2.0 mg/kg/Week
n=58 Participants
Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
|
|---|---|---|---|
|
Change From Baseline in Endurance as Measured by the 3-minute Stair Climb Test
Change from Baseline to Week 24
|
3.6 stairs/minute
Standard Deviation 8.51
|
3.2 stairs/minute
Standard Deviation 10.29
|
4.7 stairs/minute
Standard Deviation 7.99
|
|
Change From Baseline in Endurance as Measured by the 3-minute Stair Climb Test
Baseline
|
30.0 stairs/minute
Standard Deviation 14.05
|
27.1 stairs/minute
Standard Deviation 15.80
|
29.6 stairs/minute
Standard Deviation 16.44
|
|
Change From Baseline in Endurance as Measured by the 3-minute Stair Climb Test
Week 24
|
33.6 stairs/minute
Standard Deviation 18.36
|
30.4 stairs/minute
Standard Deviation 17.77
|
34.3 stairs/minute
Standard Deviation 18.70
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Intention to treat (all patients receiving at least one dose of study drug). Nine missing outcomes at Week 24 were imputed using method of multiple imputation.
Outcome measures
| Measure |
Placebo
n=59 Participants
Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
|
BMN110 2.0 mg/kg/Qow
n=59 Participants
Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
|
BMN110 2.0 mg/kg/Week
n=58 Participants
Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
|
|---|---|---|---|
|
Percent Change From Baseline in Urine Keratan Sulfate Normalized for Urine Creatinine
|
-3.6 percent change
Standard Deviation 27.41
|
-35.3 percent change
Standard Deviation 20.74
|
-43.7 percent change
Standard Deviation 22.29
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 57 other events
Deaths: 0 deaths
BMN110 2.0 mg/kg/Qow
Serious events: 4 serious events
Other events: 59 other events
Deaths: 0 deaths
BMN110 2.0 mg/kg/Week
Serious events: 9 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=59 participants at risk
Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
|
BMN110 2.0 mg/kg/Qow
n=59 participants at risk
Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
|
BMN110 2.0 mg/kg/Week
n=58 participants at risk
Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Deafness
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/58 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/58 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
General disorders
Infusion site pain
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/58 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/58 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/58 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Infections and infestations
Dengue fever
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/58 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/58 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Infections and infestations
Otitis media
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/58 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Infections and infestations
Pneumonia
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
3.4%
2/58 • Number of events 2 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/58 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Nervous system disorders
Cervical cord compression
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/58 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/58 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Surgical and medical procedures
Suture removal
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/58 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
Other adverse events
| Measure |
Placebo
n=59 participants at risk
Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
|
BMN110 2.0 mg/kg/Qow
n=59 participants at risk
Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
|
BMN110 2.0 mg/kg/Week
n=58 participants at risk
Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
|
|---|---|---|---|
|
Cardiac disorders
Mitral valve incompetence
|
6.8%
4/59 • Number of events 4 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.1%
3/59 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.2%
3/58 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Cardiac disorders
Pulmonary valve incompetence
|
3.4%
2/59 • Number of events 2 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.2%
3/58 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Cardiac disorders
Tachycardia
|
10.2%
6/59 • Number of events 7 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
3.4%
2/59 • Number of events 6 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.2%
3/58 • Number of events 8 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Cardiac disorders
Tricuspid valve incompetence
|
5.1%
3/59 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
11.9%
7/59 • Number of events 7 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
6.9%
4/58 • Number of events 4 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Ear and labyrinth disorders
Ear pain
|
8.5%
5/59 • Number of events 6 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
13.6%
8/59 • Number of events 11 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.2%
3/58 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Eye disorders
Corneal opacity
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
8.6%
5/58 • Number of events 5 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.1%
3/59 • Number of events 4 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
3.4%
2/58 • Number of events 4 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Gastrointestinal disorders
Abdominal pain
|
8.5%
5/59 • Number of events 5 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
13.6%
8/59 • Number of events 14 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
24.1%
14/58 • Number of events 23 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.5%
5/59 • Number of events 6 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
6.8%
4/59 • Number of events 4 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
15.5%
9/58 • Number of events 22 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Gastrointestinal disorders
Diarrhoea
|
11.9%
7/59 • Number of events 8 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
20.3%
12/59 • Number of events 14 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
20.7%
12/58 • Number of events 14 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Gastrointestinal disorders
Dyspepsia
|
6.8%
4/59 • Number of events 4 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/58 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Gastrointestinal disorders
Flatulence
|
5.1%
3/59 • Number of events 4 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/58 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Gastrointestinal disorders
Nausea
|
20.3%
12/59 • Number of events 13 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
23.7%
14/59 • Number of events 22 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
31.0%
18/58 • Number of events 37 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Gastrointestinal disorders
Vomiting
|
35.6%
21/59 • Number of events 42 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
35.6%
21/59 • Number of events 44 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
43.1%
25/58 • Number of events 60 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
General disorders
Chest discomfort
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.2%
3/58 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
General disorders
Chills
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
10.2%
6/59 • Number of events 7 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
10.3%
6/58 • Number of events 7 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
General disorders
Device occlusion
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
3.4%
2/59 • Number of events 2 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.2%
3/58 • Number of events 4 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
General disorders
Fatigue
|
25.4%
15/59 • Number of events 24 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
13.6%
8/59 • Number of events 10 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
15.5%
9/58 • Number of events 17 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
General disorders
Infusion site extravasation
|
3.4%
2/59 • Number of events 2 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
6.8%
4/59 • Number of events 4 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
3.4%
2/58 • Number of events 2 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
General disorders
Infusion site pain
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
6.8%
4/59 • Number of events 7 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.2%
3/58 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.1%
3/59 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/58 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
General disorders
Oedema peripheral
|
3.4%
2/59 • Number of events 2 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
6.8%
4/59 • Number of events 6 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/58 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
General disorders
Puncture site pain
|
3.4%
2/59 • Number of events 2 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.1%
3/59 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/58 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
General disorders
Pyrexia
|
28.8%
17/59 • Number of events 29 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
37.3%
22/59 • Number of events 35 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
43.1%
25/58 • Number of events 47 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Immune system disorders
Hypersensitivity
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
6.8%
4/59 • Number of events 7 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
3.4%
2/58 • Number of events 2 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Infections and infestations
Ear infection
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
3.4%
2/59 • Number of events 2 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
8.6%
5/58 • Number of events 5 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Infections and infestations
Gastroenteritis
|
6.8%
4/59 • Number of events 4 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
13.6%
8/59 • Number of events 10 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
12.1%
7/58 • Number of events 8 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Infections and infestations
Influenza
|
5.1%
3/59 • Number of events 4 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
8.5%
5/59 • Number of events 5 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
3.4%
2/58 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Infections and infestations
Nasopharyngitis
|
15.3%
9/59 • Number of events 12 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
20.3%
12/59 • Number of events 13 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
17.2%
10/58 • Number of events 11 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Infections and infestations
Otitis media
|
6.8%
4/59 • Number of events 4 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
8.5%
5/59 • Number of events 5 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
13.8%
8/58 • Number of events 9 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Infections and infestations
Pharyngitis
|
11.9%
7/59 • Number of events 7 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.1%
3/59 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
6.9%
4/58 • Number of events 4 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Infections and infestations
Rhinitis
|
10.2%
6/59 • Number of events 8 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
6.8%
4/59 • Number of events 8 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
8.6%
5/58 • Number of events 8 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Infections and infestations
Upper respiratory tract infection
|
15.3%
9/59 • Number of events 14 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
16.9%
10/59 • Number of events 13 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
17.2%
10/58 • Number of events 15 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Infections and infestations
Viral infection
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
10.2%
6/59 • Number of events 6 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.2%
3/58 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.1%
3/59 • Number of events 5 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
6.8%
4/59 • Number of events 5 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
3.4%
2/58 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
6.8%
4/59 • Number of events 5 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/58 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.1%
3/59 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
3.4%
2/58 • Number of events 2 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.1%
3/59 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/58 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Investigations
Blood pressure diastolic increased
|
3.4%
2/59 • Number of events 5 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.1%
3/59 • Number of events 4 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
3.4%
2/58 • Number of events 2 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Investigations
Blood pressure systolic increased
|
3.4%
2/59 • Number of events 5 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.1%
3/59 • Number of events 16 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/58 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Investigations
Body temperature increased
|
3.4%
2/59 • Number of events 10 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
3.4%
2/59 • Number of events 2 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
6.9%
4/58 • Number of events 24 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Investigations
Oxygen saturation decreased
|
10.2%
6/59 • Number of events 19 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
11.9%
7/59 • Number of events 8 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
10.3%
6/58 • Number of events 10 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Investigations
Respiratory rate increased
|
5.1%
3/59 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/58 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.8%
17/59 • Number of events 27 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
15.3%
9/59 • Number of events 14 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
17.2%
10/58 • Number of events 14 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.2%
6/59 • Number of events 7 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
16.9%
10/59 • Number of events 17 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
12.1%
7/58 • Number of events 10 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.1%
3/59 • Number of events 4 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
3.4%
2/59 • Number of events 2 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.2%
3/58 • Number of events 4 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.1%
3/59 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/58 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.2%
3/58 • Number of events 4 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.1%
3/59 • Number of events 5 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
8.6%
5/58 • Number of events 6 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
5.1%
3/59 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.1%
3/59 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/58 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.3%
9/59 • Number of events 13 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
23.7%
14/59 • Number of events 24 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
15.5%
9/58 • Number of events 16 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Nervous system disorders
Dizziness
|
5.1%
3/59 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
6.8%
4/59 • Number of events 6 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
12.1%
7/58 • Number of events 10 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Nervous system disorders
Headache
|
35.6%
21/59 • Number of events 38 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
40.7%
24/59 • Number of events 52 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
41.4%
24/58 • Number of events 69 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Nervous system disorders
Hyperreflexia
|
5.1%
3/59 • Number of events 6 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/59 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/58 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.2%
3/58 • Number of events 6 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Nervous system disorders
Somnolence
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.2%
3/58 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Psychiatric disorders
Agitation
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
3.4%
2/59 • Number of events 2 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.2%
3/58 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
3.4%
2/59 • Number of events 2 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.1%
3/59 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/58 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.1%
3/59 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/58 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.6%
21/59 • Number of events 28 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
28.8%
17/59 • Number of events 29 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
27.6%
16/58 • Number of events 20 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.1%
3/59 • Number of events 4 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
10.2%
6/59 • Number of events 8 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
12.1%
7/58 • Number of events 12 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.1%
3/59 • Number of events 5 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
3.4%
2/59 • Number of events 2 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.2%
3/58 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.5%
5/59 • Number of events 8 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
8.5%
5/59 • Number of events 7 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
8.6%
5/58 • Number of events 7 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.9%
7/59 • Number of events 8 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
15.3%
9/59 • Number of events 12 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
20.7%
12/58 • Number of events 14 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.8%
4/59 • Number of events 6 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
6.8%
4/59 • Number of events 9 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
8.6%
5/58 • Number of events 5 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.2%
3/58 • Number of events 4 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
5.1%
3/59 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/58 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.1%
3/59 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/58 • Number of events 2 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.1%
3/59 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
0.00%
0/58 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.4%
2/59 • Number of events 2 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.1%
3/59 • Number of events 5 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
6.9%
4/58 • Number of events 4 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.5%
5/59 • Number of events 6 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
10.2%
6/59 • Number of events 7 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
10.3%
6/58 • Number of events 9 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
6.8%
4/59 • Number of events 5 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.2%
3/58 • Number of events 5 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Vascular disorders
Flushing
|
0.00%
0/59 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
8.6%
5/58 • Number of events 7 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Vascular disorders
Hot flush
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
6.8%
4/59 • Number of events 6 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.2%
3/58 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Vascular disorders
Hypertension
|
6.8%
4/59 • Number of events 13 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
6.8%
4/59 • Number of events 18 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.2%
3/58 • Number of events 6 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Vascular disorders
Hypotension
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
3.4%
2/59 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.2%
3/58 • Number of events 3 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
|
Vascular disorders
Poor venous access
|
6.8%
4/59 • Number of events 8 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
1.7%
1/59 • Number of events 1 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
5.2%
3/58 • Number of events 4 • Study Period, through 24 weeks
Treatment Emergent Events Only
|
Additional Information
BioMarin Medical Information Services
BioMarin Pharmaceutical Inc.
Phone: (800) 983-4587
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60