Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability and Efficacy of BMN 110 in Subjects With Mucopolysaccharidosis IVA (NCT NCT00884949)
NCT ID: NCT00884949
Last Updated: 2014-06-30
Results Overview
The primary objective of the study was to evaluate the safety of weekly infusions of BMN 110 administered in escalating doses to subjects with MPS IVA. The safety variable incidence of TEAE is summarized.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Entire Study, through week 84
Results posted on
2014-06-30
Participant Flow
Participant milestones
| Measure |
BMN 110
Dose-Escalation Period:
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:
* Weeks 1-12: 0.1 mg/kg/week
* Weeks 13-24: 1.0 mg/kg/week
* Weeks 25-36: 2.0 mg/kg/week
Continuation Period:
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
|
|---|---|
|
Weeks 1-12: 0.1 mg/kg/Week
STARTED
|
20
|
|
Weeks 1-12: 0.1 mg/kg/Week
COMPLETED
|
18
|
|
Weeks 1-12: 0.1 mg/kg/Week
NOT COMPLETED
|
2
|
|
Weeks 13-24: 1.0 mg/kg/Week
STARTED
|
18
|
|
Weeks 13-24: 1.0 mg/kg/Week
COMPLETED
|
18
|
|
Weeks 13-24: 1.0 mg/kg/Week
NOT COMPLETED
|
0
|
|
Weeks 25-36: 2.0 mg/kg/Week
STARTED
|
18
|
|
Weeks 25-36: 2.0 mg/kg/Week
COMPLETED
|
18
|
|
Weeks 25-36: 2.0 mg/kg/Week
NOT COMPLETED
|
0
|
|
Continuation Period
STARTED
|
18
|
|
Continuation Period
COMPLETED
|
18
|
|
Continuation Period
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
BMN 110
Dose-Escalation Period:
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:
* Weeks 1-12: 0.1 mg/kg/week
* Weeks 13-24: 1.0 mg/kg/week
* Weeks 25-36: 2.0 mg/kg/week
Continuation Period:
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
|
|---|---|
|
Weeks 1-12: 0.1 mg/kg/Week
Adverse Event
|
1
|
|
Weeks 1-12: 0.1 mg/kg/Week
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability and Efficacy of BMN 110 in Subjects With Mucopolysaccharidosis IVA
Baseline characteristics by cohort
| Measure |
BMN 110
n=20 Participants
Dose-Escalation Period:
|
|---|---|
|
Age, Continuous
|
8.0 years
STANDARD_DEVIATION 2.89 • n=5 Participants
|
|
Age, Customized
>=4 to <8 years
|
10 participants
n=5 Participants
|
|
Age, Customized
>=8 to <10 years
|
6 participants
n=5 Participants
|
|
Age, Customized
>=10 to <=18 years
|
4 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Entire Study, through week 84The primary objective of the study was to evaluate the safety of weekly infusions of BMN 110 administered in escalating doses to subjects with MPS IVA. The safety variable incidence of TEAE is summarized.
Outcome measures
| Measure |
BMN 110
n=20 Participants
Dose-Escalation Period:
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:
* Weeks 1-12: 0.1 mg/kg/week
* Weeks 13-24: 1.0 mg/kg/week
* Weeks 25-36: 2.0 mg/kg/week
Continuation Period:
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
|
1.0 mg/kg/Week
n=18 Participants
Dose-Escalation Period: Weeks 13-24: 1.0 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 1.0 mg/kg/week
|
2.0 mg/kg/Week
n=18 Participants
Dose-Escalation Period: Weeks 25-36: 2.0 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 2.0 mg/kg/week
|
Continuation Period
n=18 Participants
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
|
Entire Study
n=20 Participants
Entire Study period includes both Dose-Escalation Period and Continuation Period.
|
|---|---|---|---|---|---|
|
Subject Incidence of Treatment Emergent AEs
Any SAEs
|
6 participants
|
2 participants
|
8 participants
|
6 participants
|
14 participants
|
|
Subject Incidence of Treatment Emergent AEs
Any AEs
|
18 participants
|
18 participants
|
17 participants
|
17 participants
|
20 participants
|
|
Subject Incidence of Treatment Emergent AEs
Any Study Drug-Related AEs
|
12 participants
|
10 participants
|
7 participants
|
8 participants
|
14 participants
|
|
Subject Incidence of Treatment Emergent AEs
Any Study Drug-Related SAEs
|
2 participants
|
1 participants
|
2 participants
|
1 participants
|
4 participants
|
|
Subject Incidence of Treatment Emergent AEs
Any AEs During Infusion
|
15 participants
|
13 participants
|
10 participants
|
15 participants
|
17 participants
|
|
Subject Incidence of Treatment Emergent AEs
Any SAEs During Infusion
|
5 participants
|
0 participants
|
1 participants
|
1 participants
|
6 participants
|
|
Subject Incidence of Treatment Emergent AEs
Any AEs Causing Study Discontinuation
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Subject Incidence of Treatment Emergent AEs
Any Study Drug-Related AE Causing Study Discont.
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Subject Incidence of Treatment Emergent AEs
AEs Causing Permanent Study Drug Discont.
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Subject Incidence of Treatment Emergent AEs
Drug-Related AE Causing Permanent StudyDrug Discon
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Subject Incidence of Treatment Emergent AEs
Any SAEs Causing Study Discontinuation
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Subject Incidence of Treatment Emergent AEs
Any SAEs Causing Permanent Study Drug Discont.
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Subject Incidence of Treatment Emergent AEs
Study Drug-Related SAE Causing Study Discont.
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Subject Incidence of Treatment Emergent AEs
StudyDrug-Related SAE Causing Permanent DrugDiscon
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Subject Incidence of Treatment Emergent AEs
Death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 12, 24, 36, 48, 72Population: Intent-to-Treat population (all subjects who enrolled in the study). Two patients were either physically (score was designated as 0 m) or developmentally (score was set to missing) unable to perform the 6MWT. The analysis was based on observed cases.
Change from baseline in meters in 6-minute Walk Test. As a measure of endurance, a 6-minute walk test (6MWT) was performed according to the American Thoracic Society Guidelines. Patients were instructed to walk as far as possible in 6 minutes.
Outcome measures
| Measure |
BMN 110
n=20 Participants
Dose-Escalation Period:
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:
* Weeks 1-12: 0.1 mg/kg/week
* Weeks 13-24: 1.0 mg/kg/week
* Weeks 25-36: 2.0 mg/kg/week
Continuation Period:
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
|
1.0 mg/kg/Week
Dose-Escalation Period: Weeks 13-24: 1.0 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 1.0 mg/kg/week
|
2.0 mg/kg/Week
Dose-Escalation Period: Weeks 25-36: 2.0 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 2.0 mg/kg/week
|
Continuation Period
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
|
Entire Study
Entire Study period includes both Dose-Escalation Period and Continuation Period.
|
|---|---|---|---|---|---|
|
Change From Baseline in 6MWT
Week 12 Change from Baseline (n=19)
|
-20.7 meters
Standard Deviation 85.95
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 6MWT
Week 24 Change from Baseline (n=17)
|
16.3 meters
Standard Deviation 71.74
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 6MWT
Week 36 Change from Baseline (n=17)
|
13.8 meters
Standard Deviation 63.25
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 6MWT
Week 48 Change from Baseline (n=17)
|
-4.8 meters
Standard Deviation 64.70
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 6MWT
Week 72 Change from Baseline (n=17)
|
4.0 meters
Standard Deviation 87.24
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Weeks 12, 24, 36, 48, 72Population: Intent-to-Treat population (all subjects who enrolled in the study). One patient was developmentally unable to perform the 3MSCT and the test scores were set to missing. The analysis was based on observed cases.
Change from baseline in the 3-minute Stair Climb Test. Patients walked up stairs that have a railing, which could be used for support, for 3 minutes, with the number of stairs climbed recorded. The test result was the number of steps climbed per minute.
Outcome measures
| Measure |
BMN 110
n=20 Participants
Dose-Escalation Period:
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:
* Weeks 1-12: 0.1 mg/kg/week
* Weeks 13-24: 1.0 mg/kg/week
* Weeks 25-36: 2.0 mg/kg/week
Continuation Period:
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
|
1.0 mg/kg/Week
Dose-Escalation Period: Weeks 13-24: 1.0 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 1.0 mg/kg/week
|
2.0 mg/kg/Week
Dose-Escalation Period: Weeks 25-36: 2.0 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 2.0 mg/kg/week
|
Continuation Period
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
|
Entire Study
Entire Study period includes both Dose-Escalation Period and Continuation Period.
|
|---|---|---|---|---|---|
|
Change From Baseline in 3MSCT
Week 12 Change from Baseline (n=19)
|
0.3 steps/min
Standard Deviation 14.07
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 3MSCT
Week 24 Change from Baseline (n=17)
|
6.1 steps/min
Standard Deviation 8.66
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 3MSCT
Week 36 Change from Baseline (n=17)
|
7.8 steps/min
Standard Deviation 13.69
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 3MSCT
Week 48 Change from Baseline (n=17)
|
9.7 steps/min
Standard Deviation 14.42
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 3MSCT
Week 72 Change from Baseline (n=17)
|
9.7 steps/min
Standard Deviation 13.91
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Weeks 12, 24, 36, 72Population: Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.
Percent Change from baseline in Normalized Urine KS. The percent change was calculated (Week X value - baseline value)/baseline value \*100%
Outcome measures
| Measure |
BMN 110
n=20 Participants
Dose-Escalation Period:
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:
* Weeks 1-12: 0.1 mg/kg/week
* Weeks 13-24: 1.0 mg/kg/week
* Weeks 25-36: 2.0 mg/kg/week
Continuation Period:
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
|
1.0 mg/kg/Week
Dose-Escalation Period: Weeks 13-24: 1.0 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 1.0 mg/kg/week
|
2.0 mg/kg/Week
Dose-Escalation Period: Weeks 25-36: 2.0 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 2.0 mg/kg/week
|
Continuation Period
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
|
Entire Study
Entire Study period includes both Dose-Escalation Period and Continuation Period.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in uKS
Week 12 Percent Change from Baseline (n=19)
|
-23.2 percentage of uKS
Standard Deviation 19.04
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in uKS
Week 24 Percent Change from Baseline (n=18)
|
-27.9 percentage of uKS
Standard Deviation 17.92
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in uKS
Week 36 Percent Change from Baseline (n=18)
|
-40.6 percentage of uKS
Standard Deviation 20.16
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in uKS
Week 72 Percent Change from Baseline (n=17)
|
-32.2 percentage of uKS
Standard Deviation 17.10
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Weeks 12, 24, 36, 72Population: Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.
Percent Change from baseline in Maximum Voluntary Ventilation.
Outcome measures
| Measure |
BMN 110
n=20 Participants
Dose-Escalation Period:
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:
* Weeks 1-12: 0.1 mg/kg/week
* Weeks 13-24: 1.0 mg/kg/week
* Weeks 25-36: 2.0 mg/kg/week
Continuation Period:
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
|
1.0 mg/kg/Week
Dose-Escalation Period: Weeks 13-24: 1.0 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 1.0 mg/kg/week
|
2.0 mg/kg/Week
Dose-Escalation Period: Weeks 25-36: 2.0 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 2.0 mg/kg/week
|
Continuation Period
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
|
Entire Study
Entire Study period includes both Dose-Escalation Period and Continuation Period.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in MVV
Week 12 Percent Change from Baseline (n=14)
|
9.9 percentage of MVV
Standard Deviation 21.29
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in MVV
Week 24 Percent Change from Baseline (n=13)
|
11.0 percentage of MVV
Standard Deviation 21.48
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in MVV
Week 36 Percent Change from Baseline (n=14)
|
10.5 percentage of MVV
Standard Deviation 17.43
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in MVV
Week 72 Percent Change from Baseline (n=14)
|
18.4 percentage of MVV
Standard Deviation 20.77
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Weeks 12, 24, 36, 72Population: Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.
Percent Change from baseline in Forced Vital Capacity.
Outcome measures
| Measure |
BMN 110
n=20 Participants
Dose-Escalation Period:
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:
* Weeks 1-12: 0.1 mg/kg/week
* Weeks 13-24: 1.0 mg/kg/week
* Weeks 25-36: 2.0 mg/kg/week
Continuation Period:
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
|
1.0 mg/kg/Week
Dose-Escalation Period: Weeks 13-24: 1.0 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 1.0 mg/kg/week
|
2.0 mg/kg/Week
Dose-Escalation Period: Weeks 25-36: 2.0 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 2.0 mg/kg/week
|
Continuation Period
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
|
Entire Study
Entire Study period includes both Dose-Escalation Period and Continuation Period.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in FVC
Week 12 Percent Change from Baseline (n=18)
|
3.4 percentage of FVC
Standard Deviation 10.85
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in FVC
Week 24 Percent Change from Baseline (n=16)
|
0.2 percentage of FVC
Standard Deviation 16.60
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in FVC
Week 36 Percent Change from Baseline (n=16)
|
10.7 percentage of FVC
Standard Deviation 20.82
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in FVC
Week 72 Percent Change from Baseline (n=16)
|
12.5 percentage of FVC
Standard Deviation 14.88
|
—
|
—
|
—
|
—
|
Adverse Events
0.1 mg/kg/Week
Serious events: 6 serious events
Other events: 18 other events
Deaths: 0 deaths
1.0 mg/kg/Week
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
2.0 mg/kg/Week
Serious events: 8 serious events
Other events: 16 other events
Deaths: 0 deaths
Continuation Period
Serious events: 6 serious events
Other events: 17 other events
Deaths: 0 deaths
Entire Study
Serious events: 14 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.1 mg/kg/Week
n=20 participants at risk
Dose-Escalation Period: Weeks 1-12: 0.1 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 0.1 mg/kg/week
|
1.0 mg/kg/Week
n=18 participants at risk
Dose-Escalation Period: Weeks 13-24: 1.0 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 1.0 mg/kg/week
|
2.0 mg/kg/Week
n=18 participants at risk
Dose-Escalation Period: Weeks 25-36: 2.0 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 2.0 mg/kg/week
|
Continuation Period
n=18 participants at risk
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
|
Entire Study
n=20 participants at risk
Entire Study period includes both Dose-Escalation Period and Continuation Period.
|
|---|---|---|---|---|---|
|
General disorders
Gait disturbance
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
General disorders
Infusion related reaction
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 4 • Study Period, through 84 weeks
All Adverse Events
|
|
Immune system disorders
Type I hypersensitivity
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Abdominal abscess
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Abscess limb
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Implant site infection
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Otitis media
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Knee deformity
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
25.0%
5/20 • Number of events 5 • Study Period, through 84 weeks
All Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Surgical and medical procedures
Abscess drainage
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Surgical and medical procedures
Catheterisation venous
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
16.7%
3/18 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
15.0%
3/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
|
Vascular disorders
Poor venous access
|
15.0%
3/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
20.0%
4/20 • Number of events 5 • Study Period, through 84 weeks
All Adverse Events
|
Other adverse events
| Measure |
0.1 mg/kg/Week
n=20 participants at risk
Dose-Escalation Period: Weeks 1-12: 0.1 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 0.1 mg/kg/week
|
1.0 mg/kg/Week
n=18 participants at risk
Dose-Escalation Period: Weeks 13-24: 1.0 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 1.0 mg/kg/week
|
2.0 mg/kg/Week
n=18 participants at risk
Dose-Escalation Period: Weeks 25-36: 2.0 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 2.0 mg/kg/week
|
Continuation Period
n=18 participants at risk
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
|
Entire Study
n=20 participants at risk
Entire Study period includes both Dose-Escalation Period and Continuation Period.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Ear and labyrinth disorders
Ear canal erythema
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Ear and labyrinth disorders
Ear pain
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
27.8%
5/18 • Number of events 10 • Study Period, through 84 weeks
All Adverse Events
|
25.0%
5/20 • Number of events 16 • Study Period, through 84 weeks
All Adverse Events
|
|
Ear and labyrinth disorders
External ear disorder
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Ear and labyrinth disorders
Hypoacusis
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Ear and labyrinth disorders
Inner ear disorder
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Ear and labyrinth disorders
Motion sickness
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Eye disorders
Conjunctivitis
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Eye disorders
Eye discharge
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Eye disorders
Eyelid cyst
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Gastrointestinal disorders
Abdominal pain
|
15.0%
3/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
20.0%
4/20 • Number of events 10 • Study Period, through 84 weeks
All Adverse Events
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
4/20 • Number of events 8 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
16.7%
3/18 • Number of events 6 • Study Period, through 84 weeks
All Adverse Events
|
22.2%
4/18 • Number of events 4 • Study Period, through 84 weeks
All Adverse Events
|
40.0%
8/20 • Number of events 20 • Study Period, through 84 weeks
All Adverse Events
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
15.0%
3/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
16.7%
3/18 • Number of events 4 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
30.0%
6/20 • Number of events 8 • Study Period, through 84 weeks
All Adverse Events
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
15.0%
3/20 • Number of events 5 • Study Period, through 84 weeks
All Adverse Events
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Gastrointestinal disorders
Toothache
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
20.0%
4/20 • Number of events 5 • Study Period, through 84 weeks
All Adverse Events
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
38.9%
7/18 • Number of events 7 • Study Period, through 84 weeks
All Adverse Events
|
22.2%
4/18 • Number of events 6 • Study Period, through 84 weeks
All Adverse Events
|
66.7%
12/18 • Number of events 26 • Study Period, through 84 weeks
All Adverse Events
|
65.0%
13/20 • Number of events 42 • Study Period, through 84 weeks
All Adverse Events
|
|
General disorders
Application site vesicles
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
General disorders
Catheter site erythema
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
General disorders
Catheter site pain
|
15.0%
3/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
15.0%
3/20 • Number of events 4 • Study Period, through 84 weeks
All Adverse Events
|
|
General disorders
Chills
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
General disorders
Extravasation
|
5.0%
1/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
General disorders
Feeling hot
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
General disorders
Gait disturbance
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
General disorders
Implant site erythema
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 4 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 4 • Study Period, through 84 weeks
All Adverse Events
|
|
General disorders
Implant site extravasation
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
General disorders
Implant site rash
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
General disorders
Influenza like illness
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
General disorders
Infusion site erythema
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
General disorders
Infusion site inflammation
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
General disorders
Infusion site oedema
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
General disorders
Injection site pain
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
General disorders
Injection site reaction
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
General disorders
Malaise
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
|
General disorders
Pyrexia
|
30.0%
6/20 • Number of events 6 • Study Period, through 84 weeks
All Adverse Events
|
50.0%
9/18 • Number of events 12 • Study Period, through 84 weeks
All Adverse Events
|
27.8%
5/18 • Number of events 8 • Study Period, through 84 weeks
All Adverse Events
|
55.6%
10/18 • Number of events 20 • Study Period, through 84 weeks
All Adverse Events
|
70.0%
14/20 • Number of events 46 • Study Period, through 84 weeks
All Adverse Events
|
|
Hepatobiliary disorders
Hepatomegaly
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Immune system disorders
Hypersensitivity
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Abdominal abscess
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Ear infection
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
16.7%
3/18 • Number of events 4 • Study Period, through 84 weeks
All Adverse Events
|
25.0%
5/20 • Number of events 6 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Eye infection
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Helminthic infection
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Impetigo
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Infection
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Lice infestation
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Localised infection
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Nail infection
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
2/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
16.7%
3/18 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
22.2%
4/18 • Number of events 6 • Study Period, through 84 weeks
All Adverse Events
|
40.0%
8/20 • Number of events 13 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Otitis externa
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Rhinitis
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Skin infection
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Infections and infestations
Varicella
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 4 • Study Period, through 84 weeks
All Adverse Events
|
|
Injury, poisoning and procedural complications
Device migration
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
2/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
25.0%
5/20 • Number of events 7 • Study Period, through 84 weeks
All Adverse Events
|
|
Injury, poisoning and procedural complications
Head injury
|
10.0%
2/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
20.0%
4/20 • Number of events 7 • Study Period, through 84 weeks
All Adverse Events
|
|
Injury, poisoning and procedural complications
Injury
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Injury, poisoning and procedural complications
Medical device complication
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Injury, poisoning and procedural complications
Thermal burn
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Investigations
Blood immunoglobulin E increased
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Investigations
Blood immunoglobulin G decreased
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Investigations
Blood sodium increased
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Investigations
Cardiac murmur
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Investigations
Computerised tomogram
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Investigations
Echocardiogram abnormal
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Investigations
Electrocardiogram T wave amplitude decreased
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Investigations
Eosinophil count increased
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Investigations
Nuclear magnetic resonance imaging
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
22.2%
4/18 • Number of events 4 • Study Period, through 84 weeks
All Adverse Events
|
30.0%
6/20 • Number of events 7 • Study Period, through 84 weeks
All Adverse Events
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
|
Investigations
Protein total abnormal
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Investigations
Respiratory rate increased
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Investigations
Weight increased
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.0%
3/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
16.7%
3/18 • Number of events 4 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
22.2%
4/18 • Number of events 4 • Study Period, through 84 weeks
All Adverse Events
|
40.0%
8/20 • Number of events 11 • Study Period, through 84 weeks
All Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
16.7%
3/18 • Number of events 4 • Study Period, through 84 weeks
All Adverse Events
|
20.0%
4/20 • Number of events 5 • Study Period, through 84 weeks
All Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
15.0%
3/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
4/20 • Number of events 6 • Study Period, through 84 weeks
All Adverse Events
|
16.7%
3/18 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
22.2%
4/18 • Number of events 5 • Study Period, through 84 weeks
All Adverse Events
|
50.0%
10/20 • Number of events 15 • Study Period, through 84 weeks
All Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Nervous system disorders
Ageusia
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Nervous system disorders
Clonus
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
|
Nervous system disorders
Headache
|
20.0%
4/20 • Number of events 8 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 8 • Study Period, through 84 weeks
All Adverse Events
|
33.3%
6/18 • Number of events 16 • Study Period, through 84 weeks
All Adverse Events
|
45.0%
9/20 • Number of events 35 • Study Period, through 84 weeks
All Adverse Events
|
|
Nervous system disorders
Lethargy
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Renal and urinary disorders
Enuresis
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Reproductive system and breast disorders
Balanitis
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
27.8%
5/18 • Number of events 7 • Study Period, through 84 weeks
All Adverse Events
|
16.7%
3/18 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
55.6%
10/18 • Number of events 18 • Study Period, through 84 weeks
All Adverse Events
|
65.0%
13/20 • Number of events 29 • Study Period, through 84 weeks
All Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
15.0%
3/20 • Number of events 4 • Study Period, through 84 weeks
All Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
22.2%
4/18 • Number of events 4 • Study Period, through 84 weeks
All Adverse Events
|
30.0%
6/20 • Number of events 6 • Study Period, through 84 weeks
All Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
16.7%
3/18 • Number of events 4 • Study Period, through 84 weeks
All Adverse Events
|
20.0%
4/20 • Number of events 6 • Study Period, through 84 weeks
All Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
10.0%
2/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 3 • Study Period, through 84 weeks
All Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
15.0%
3/20 • Number of events 4 • Study Period, through 84 weeks
All Adverse Events
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Surgical and medical procedures
Cautery to nose
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Surgical and medical procedures
Induction of anaesthesia
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Vascular disorders
Flushing
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
11.1%
2/18 • Number of events 2 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
15.0%
3/20 • Number of events 4 • Study Period, through 84 weeks
All Adverse Events
|
|
Vascular disorders
Hot flush
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Vascular disorders
Hypotension
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
|
Vascular disorders
Poor venous access
|
0.00%
0/20 • Study Period, through 84 weeks
All Adverse Events
|
5.6%
1/18 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
0.00%
0/18 • Study Period, through 84 weeks
All Adverse Events
|
5.0%
1/20 • Number of events 1 • Study Period, through 84 weeks
All Adverse Events
|
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 PI cannot publish any data prior to multi-centre publication. If publication related to sub-sets of data shall make reference to the relevant multi-centre publication. PI agrees to submit data to Sponsor for review and comment 60 days prior to publication. During review period, Sponsor may request that publication be delayed for up to 6 months from date of first submission to Sponsor in order for Sponsor to take steps to protect its proprietary information.
- Publication restrictions are in place
Restriction type: OTHER