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A Study to Evaluate the Safety, Tolerability and Efficacy of BMN 110 in Subjects With Mucopolysaccharidosis IVA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00884949
Recruitment Status : Completed
First Posted : April 21, 2009
Results First Posted : June 30, 2014
Last Update Posted : June 30, 2014
Sponsor:
Information provided by (Responsible Party):
BioMarin Pharmaceutical

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition MPS IV A
Intervention Drug: BMN 110
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BMN 110
Hide Arm/Group Description

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.

Period Title: Weeks 1-12: 0.1 mg/kg/Week
Started 20
Completed 18
Not Completed 2
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             1
Period Title: Weeks 13-24: 1.0 mg/kg/Week
Started 18
Completed 18
Not Completed 0
Period Title: Weeks 25-36: 2.0 mg/kg/Week
Started 18
Completed 18
Not Completed 0
Period Title: Continuation Period
Started 18
Completed 18
Not Completed 0
Arm/Group Title BMN 110
Hide Arm/Group Description Dose-Escalation Period:
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
8.0  (2.89)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
>=4 to <8 years 10
>=8 to <10 years 6
>=10 to <=18 years 4
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
8
  40.0%
Male
12
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
20
 100.0%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native 0
Asian 9
Native Hawaiian or Other Pacific Islander 0
Black or African American 0
White 9
Other 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 20 participants
20
1.Primary Outcome
Title Subject Incidence of Treatment Emergent AEs
Hide Description

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.

Time Frame Entire Study, through week 84
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0.1 mg/kg/Week 1.0 mg/kg/Week 2.0 mg/kg/Week Continuation Period Entire Study
Hide Arm/Group Description:

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

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

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

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 period includes both Dose-Escalation Period and Continuation Period.
Overall Number of Participants Analyzed 20 18 18 18 20
Measure Type: Number
Unit of Measure: participants
Any AEs 18 18 17 17 20
Any Study Drug-Related AEs 12 10 7 8 14
Any SAEs 6 2 8 6 14
Any Study Drug-Related SAEs 2 1 2 1 4
Any AEs During Infusion 15 13 10 15 17
Any SAEs During Infusion 5 0 1 1 6
Any AEs Causing Study Discontinuation 1 0 0 0 1
Any Study Drug-Related AE Causing Study Discont. 1 0 0 0 1
AEs Causing Permanent Study Drug Discont. 1 0 0 0 1
Drug-Related AE Causing Permanent StudyDrug Discon 1 0 0 0 1
Any SAEs Causing Study Discontinuation 1 0 0 0 1
Any SAEs Causing Permanent Study Drug Discont. 1 0 0 0 1
Study Drug-Related SAE Causing Study Discont. 1 0 0 0 1
StudyDrug-Related SAE Causing Permanent DrugDiscon 1 0 0 0 1
Death 0 0 0 0 0
2.Secondary Outcome
Title Change From Baseline in 6MWT
Hide Description 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.
Time Frame Baseline to Weeks 12, 24, 36, 48, 72
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title BMN 110
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: meters
Week 12 Change from Baseline (n=19) -20.7  (85.95)
Week 24 Change from Baseline (n=17) 16.3  (71.74)
Week 36 Change from Baseline (n=17) 13.8  (63.25)
Week 48 Change from Baseline (n=17) -4.8  (64.70)
Week 72 Change from Baseline (n=17) 4.0  (87.24)
3.Secondary Outcome
Title Change From Baseline in 3MSCT
Hide Description 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.
Time Frame Baseline to Weeks 12, 24, 36, 48, 72
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title BMN 110
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: steps/min
Week 12 Change from Baseline (n=19) 0.3  (14.07)
Week 24 Change from Baseline (n=17) 6.1  (8.66)
Week 36 Change from Baseline (n=17) 7.8  (13.69)
Week 48 Change from Baseline (n=17) 9.7  (14.42)
Week 72 Change from Baseline (n=17) 9.7  (13.91)
4.Secondary Outcome
Title Percent Change From Baseline in uKS
Hide Description Percent Change from baseline in Normalized Urine KS. The percent change was calculated (Week X value - baseline value)/baseline value *100%
Time Frame Baseline to Weeks 12, 24, 36, 72
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.
Arm/Group Title BMN 110
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percentage of uKS
Week 12 Percent Change from Baseline (n=19) -23.2  (19.04)
Week 24 Percent Change from Baseline (n=18) -27.9  (17.92)
Week 36 Percent Change from Baseline (n=18) -40.6  (20.16)
Week 72 Percent Change from Baseline (n=17) -32.2  (17.10)
5.Secondary Outcome
Title Percent Change From Baseline in MVV
Hide Description Percent Change from baseline in Maximum Voluntary Ventilation.
Time Frame Baseline to Weeks 12, 24, 36, 72
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.
Arm/Group Title BMN 110
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percentage of MVV
Week 12 Percent Change from Baseline (n=14) 9.9  (21.29)
Week 24 Percent Change from Baseline (n=13) 11.0  (21.48)
Week 36 Percent Change from Baseline (n=14) 10.5  (17.43)
Week 72 Percent Change from Baseline (n=14) 18.4  (20.77)
6.Secondary Outcome
Title Percent Change From Baseline in FVC
Hide Description Percent Change from baseline in Forced Vital Capacity.
Time Frame Baseline to Weeks 12, 24, 36, 72
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.
Arm/Group Title BMN 110
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percentage of FVC
Week 12 Percent Change from Baseline (n=18) 3.4  (10.85)
Week 24 Percent Change from Baseline (n=16) 0.2  (16.60)
Week 36 Percent Change from Baseline (n=16) 10.7  (20.82)
Week 72 Percent Change from Baseline (n=16) 12.5  (14.88)
Time Frame Study Period, through 84 weeks
Adverse Event Reporting Description All Adverse Events
 
Arm/Group Title 0.1 mg/kg/Week 1.0 mg/kg/Week 2.0 mg/kg/Week Continuation Period Entire Study
Hide Arm/Group Description

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

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

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

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 period includes both Dose-Escalation Period and Continuation Period.
All-Cause Mortality
0.1 mg/kg/Week 1.0 mg/kg/Week 2.0 mg/kg/Week Continuation Period Entire Study
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
0.1 mg/kg/Week 1.0 mg/kg/Week 2.0 mg/kg/Week Continuation Period Entire Study
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/20 (30.00%)      2/18 (11.11%)      8/18 (44.44%)      6/18 (33.33%)      14/20 (70.00%)    
General disorders           
Gait disturbance  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 1/20 (5.00%)  1
Infusion related reaction  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  3 1/20 (5.00%)  4
Immune system disorders           
Type I hypersensitivity  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Infections and infestations           
Abdominal abscess  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Abscess limb  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Catheter site infection  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 1/20 (5.00%)  1
Implant site infection  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 1/20 (5.00%)  1
Lower respiratory tract infection  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1 2/20 (10.00%)  2
Otitis media  1  2/20 (10.00%)  2 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 2/20 (10.00%)  2
Pneumonia  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Injury, poisoning and procedural complications           
Road traffic accident  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders           
Knee deformity  1  1/20 (5.00%)  1 0/18 (0.00%)  0 2/18 (11.11%)  2 2/18 (11.11%)  2 5/20 (25.00%)  5
Pain in extremity  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Skin and subcutaneous tissue disorders           
Drug eruption  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Rash generalised  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Rash maculo-papular  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Surgical and medical procedures           
Abscess drainage  1  1/20 (5.00%)  1 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  2
Catheterisation venous  1  0/20 (0.00%)  0 0/18 (0.00%)  0 3/18 (16.67%)  3 0/18 (0.00%)  0 3/20 (15.00%)  3
Vascular disorders           
Poor venous access  1  3/20 (15.00%)  3 0/18 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1 4/20 (20.00%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
0.1 mg/kg/Week 1.0 mg/kg/Week 2.0 mg/kg/Week Continuation Period Entire Study
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/20 (90.00%)      18/18 (100.00%)      16/18 (88.89%)      17/18 (94.44%)      20/20 (100.00%)    
Blood and lymphatic system disorders           
Lymphadenopathy  1  0/20 (0.00%)  0 2/18 (11.11%)  2 0/18 (0.00%)  0 0/18 (0.00%)  0 2/20 (10.00%)  2
Cardiac disorders           
Mitral valve disease  1  0/20 (0.00%)  0 0/18 (0.00%)  0 2/18 (11.11%)  2 0/18 (0.00%)  0 2/20 (10.00%)  2
Tachycardia  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Ear and labyrinth disorders           
Cerumen impaction  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Deafness neurosensory  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Ear canal erythema  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Ear disorder  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Ear pain  1  1/20 (5.00%)  1 1/18 (5.56%)  2 1/18 (5.56%)  3 5/18 (27.78%)  10 5/20 (25.00%)  16
External ear disorder  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 1/20 (5.00%)  1
Hyperacusis  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Hypoacusis  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 2/20 (10.00%)  2
Inner ear disorder  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Motion sickness  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Otorrhoea  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Tinnitus  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Endocrine disorders           
Autoimmune thyroiditis  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 1/20 (5.00%)  1
Eye disorders           
Conjunctivitis  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 2/20 (10.00%)  2
Eye discharge  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Eyelid cyst  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Gastrointestinal disorders           
Abdominal pain  1  3/20 (15.00%)  3 1/18 (5.56%)  2 1/18 (5.56%)  3 1/18 (5.56%)  2 4/20 (20.00%)  10
Abdominal pain upper  1  4/20 (20.00%)  8 1/18 (5.56%)  2 3/18 (16.67%)  6 4/18 (22.22%)  4 8/20 (40.00%)  20
Constipation  1  1/20 (5.00%)  1 1/18 (5.56%)  1 0/18 (0.00%)  0 1/18 (5.56%)  1 3/20 (15.00%)  3
Dental caries  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 2/18 (11.11%)  2 2/20 (10.00%)  2
Diarrhoea  1  0/20 (0.00%)  0 2/18 (11.11%)  2 3/18 (16.67%)  4 1/18 (5.56%)  2 6/20 (30.00%)  8
Faecal incontinence  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Gastrooesophageal reflux disease  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Glossodynia  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Nausea  1  1/20 (5.00%)  1 1/18 (5.56%)  1 0/18 (0.00%)  0 2/18 (11.11%)  3 3/20 (15.00%)  5
Retching  1  0/20 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1 0/18 (0.00%)  0 1/20 (5.00%)  2
Salivary gland enlargement  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Toothache  1  1/20 (5.00%)  1 2/18 (11.11%)  2 1/18 (5.56%)  1 1/18 (5.56%)  1 4/20 (20.00%)  5
Vomiting  1  2/20 (10.00%)  3 7/18 (38.89%)  7 4/18 (22.22%)  6 12/18 (66.67%)  26 13/20 (65.00%)  42
General disorders           
Application site vesicles  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Catheter site erythema  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  2
Catheter site pain  1  3/20 (15.00%)  3 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 3/20 (15.00%)  4
Chills  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 1/20 (5.00%)  1
Extravasation  1  1/20 (5.00%)  2 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  2
Feeling hot  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1 2/20 (10.00%)  2
Gait disturbance  1  2/20 (10.00%)  2 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 2/20 (10.00%)  2
Implant site erythema  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  4 1/20 (5.00%)  4
Implant site extravasation  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Implant site rash  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Influenza like illness  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Infusion site erythema  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1 1/20 (5.00%)  2
Infusion site inflammation  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Infusion site oedema  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Injection site pain  1  0/20 (0.00%)  0 2/18 (11.11%)  2 0/18 (0.00%)  0 0/18 (0.00%)  0 2/20 (10.00%)  2
Injection site reaction  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Malaise  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  2 1/20 (5.00%)  3
Pyrexia  1  6/20 (30.00%)  6 9/18 (50.00%)  12 5/18 (27.78%)  8 10/18 (55.56%)  20 14/20 (70.00%)  46
Hepatobiliary disorders           
Hepatomegaly  1  1/20 (5.00%)  1 1/18 (5.56%)  1 0/18 (0.00%)  0 1/18 (5.56%)  1 2/20 (10.00%)  3
Immune system disorders           
Drug hypersensitivity  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 1/20 (5.00%)  1
Hypersensitivity  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Infections and infestations           
Abdominal abscess  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Catheter site infection  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 1/20 (5.00%)  1
Ear infection  1  1/20 (5.00%)  1 1/18 (5.56%)  1 0/18 (0.00%)  0 3/18 (16.67%)  4 5/20 (25.00%)  6
Eye infection  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 1/18 (5.56%)  1 2/20 (10.00%)  2
Gastroenteritis viral  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 1/20 (5.00%)  1
Helminthic infection  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Impetigo  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  3 1/20 (5.00%)  3
Infection  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Lice infestation  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1 1/20 (5.00%)  2
Localised infection  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Lower respiratory tract infection  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 2/18 (11.11%)  2 2/20 (10.00%)  2
Nail infection  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Nasopharyngitis  1  2/20 (10.00%)  3 3/18 (16.67%)  3 1/18 (5.56%)  1 4/18 (22.22%)  6 8/20 (40.00%)  13
Otitis externa  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 1/20 (5.00%)  1
Pharyngitis  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 2/18 (11.11%)  2 2/20 (10.00%)  2
Rhinitis  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 2/18 (11.11%)  2 2/20 (10.00%)  2
Skin infection  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Subcutaneous abscess  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Tinea pedis  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Tonsillitis  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Varicella  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Injury, poisoning and procedural complications           
Arthropod bite  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Arthropod sting  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Contusion  1  0/20 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1 2/18 (11.11%)  2 2/20 (10.00%)  4
Device migration  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 2/18 (11.11%)  2 2/20 (10.00%)  3
Excoriation  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Eye injury  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Face injury  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  2 1/20 (5.00%)  2
Fall  1  2/20 (10.00%)  3 0/18 (0.00%)  0 2/18 (11.11%)  2 1/18 (5.56%)  2 5/20 (25.00%)  7
Head injury  1  2/20 (10.00%)  3 1/18 (5.56%)  2 1/18 (5.56%)  1 1/18 (5.56%)  1 4/20 (20.00%)  7
Injury  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 2/20 (10.00%)  2
Joint injury  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Medical device complication  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 2/18 (11.11%)  2 2/20 (10.00%)  2
Mouth injury  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Procedural pain  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 2/18 (11.11%)  2 2/20 (10.00%)  2
Procedural vomiting  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Thermal burn  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Investigations           
Alanine aminotransferase increased  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Aspartate aminotransferase increased  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Blood immunoglobulin E increased  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Blood immunoglobulin G decreased  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Blood lactate dehydrogenase increased  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Blood sodium increased  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 1/20 (5.00%)  1
Cardiac murmur  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Computerised tomogram  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Echocardiogram abnormal  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 1/20 (5.00%)  1
Electrocardiogram T wave amplitude decreased  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 1/20 (5.00%)  1
Eosinophil count increased  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 2/20 (10.00%)  2
Nuclear magnetic resonance imaging  1  1/20 (5.00%)  1 2/18 (11.11%)  2 0/18 (0.00%)  0 4/18 (22.22%)  4 6/20 (30.00%)  7
Oxygen saturation decreased  1  0/20 (0.00%)  0 1/18 (5.56%)  3 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  3
Protein total abnormal  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Respiratory rate increased  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Weight increased  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Metabolism and nutrition disorders           
Dehydration  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 1/20 (5.00%)  1
Hypercholesterolaemia  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders           
Arthralgia  1  3/20 (15.00%)  3 3/18 (16.67%)  4 0/18 (0.00%)  0 4/18 (22.22%)  4 8/20 (40.00%)  11
Back pain  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 3/18 (16.67%)  4 4/20 (20.00%)  5
Bursitis  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Mobility decreased  1  1/20 (5.00%)  1 0/18 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1 3/20 (15.00%)  3
Muscular weakness  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Neck pain  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Pain in extremity  1  4/20 (20.00%)  6 3/18 (16.67%)  3 1/18 (5.56%)  1 4/18 (22.22%)  5 10/20 (50.00%)  15
Pain in jaw  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Nervous system disorders           
Ageusia  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Clonus  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Dizziness  1  2/20 (10.00%)  3 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 2/20 (10.00%)  3
Headache  1  4/20 (20.00%)  8 2/18 (11.11%)  3 1/18 (5.56%)  8 6/18 (33.33%)  16 9/20 (45.00%)  35
Lethargy  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Spinal cord compression  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Psychiatric disorders           
Insomnia  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Renal and urinary disorders           
Enuresis  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Incontinence  1  0/20 (0.00%)  0 1/18 (5.56%)  3 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  3
Urinary incontinence  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 2/18 (11.11%)  2 2/20 (10.00%)  2
Reproductive system and breast disorders           
Balanitis  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Penile pain  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders           
Cough  1  1/20 (5.00%)  1 5/18 (27.78%)  7 3/18 (16.67%)  3 10/18 (55.56%)  18 13/20 (65.00%)  29
Dry throat  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Dyspnoea  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Epistaxis  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Nasal congestion  1  1/20 (5.00%)  1 0/18 (0.00%)  0 1/18 (5.56%)  2 1/18 (5.56%)  1 3/20 (15.00%)  4
Oropharyngeal pain  1  0/20 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1 4/18 (22.22%)  4 6/20 (30.00%)  6
Pharyngeal oedema  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Productive cough  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 1/20 (5.00%)  1
Rales  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 1/20 (5.00%)  1
Wheezing  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Skin and subcutaneous tissue disorders           
Dermatitis diaper  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Dry skin  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 1/18 (5.56%)  1 2/20 (10.00%)  2
Erythema  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 2/18 (11.11%)  2 2/20 (10.00%)  2
Petechiae  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Pruritus  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Psoriasis  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Rash  1  1/20 (5.00%)  1 1/18 (5.56%)  1 0/18 (0.00%)  0 3/18 (16.67%)  4 4/20 (20.00%)  6
Rash generalised  1  0/20 (0.00%)  0 1/18 (5.56%)  2 0/18 (0.00%)  0 1/18 (5.56%)  1 2/20 (10.00%)  3
Rash maculo-papular  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  3 1/20 (5.00%)  3
Rash papular  1  0/20 (0.00%)  0 1/18 (5.56%)  3 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  3
Rash pruritic  1  1/20 (5.00%)  1 1/18 (5.56%)  1 0/18 (0.00%)  0 1/18 (5.56%)  2 3/20 (15.00%)  4
Skin disorder  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  2 1/20 (5.00%)  2
Skin lesion  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Skin ulcer  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Surgical and medical procedures           
Cautery to nose  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Induction of anaesthesia  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Vascular disorders           
Flushing  1  0/20 (0.00%)  0 2/18 (11.11%)  2 1/18 (5.56%)  1 1/18 (5.56%)  1 3/20 (15.00%)  4
Hot flush  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 1/20 (5.00%)  1
Hypotension  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Poor venous access  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: BioMarin Medical Information Services
Organization: BioMarin Pharmaceutical Inc.
Phone: 800-983-4587
EMail: medinfo@bmrn.com
Layout table for additonal information
Responsible Party: BioMarin Pharmaceutical
ClinicalTrials.gov Identifier: NCT00884949     History of Changes
Other Study ID Numbers: MOR-002
First Submitted: April 10, 2009
First Posted: April 21, 2009
Results First Submitted: March 13, 2014
Results First Posted: June 30, 2014
Last Update Posted: June 30, 2014