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Extension Study for Patients Who Have Participated in a BMN 701 Study

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ClinicalTrials.gov Identifier: NCT01435772
Recruitment Status : Terminated (The study was terminated because BioMarin decided to end the overall development program based on competing corporate priorities.)
First Posted : September 19, 2011
Results First Posted : May 22, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
BioMarin Pharmaceutical

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pompe Disease
Intervention Biological: BMN 701
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BMN 701 5 mg/kg BMN 701 10 mg/kg BMN 701 20 mg/kg
Hide Arm/Group Description IV infusion at dose levels of 5 mg/kg IV infusion at dose levels of 10 mg/kg IV infusion at dose levels of 20 mg/kg
Period Title: Overall Study
Started 3 3 15
Completed 0 0 0
Not Completed 3 3 15
Reason Not Completed
Adverse Event             1             0             2
Withdrawal by Subject             0             1             3
Other - study termination             2             2             10
Arm/Group Title BMN 701 5 mg/kg BMN 701 10 mg/kg BMN 701 20 mg/kg Total
Hide Arm/Group Description IV infusion at dose levels of 5 mg/kg IV infusion at dose levels of 10 mg/kg IV infusion at dose levels of 20 mg/kg Total of all reporting groups
Overall Number of Baseline Participants 3 3 15 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 15 participants 21 participants
52.3  (6.66) 42.7  (13.05) 50.1  (5.28) 49.4  (7.03)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
18-65 years Number Analyzed 3 participants 3 participants 15 participants 21 participants
3
 100.0%
3
 100.0%
15
 100.0%
21
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 15 participants 21 participants
Female
0
   0.0%
2
  66.7%
6
  40.0%
8
  38.1%
Male
3
 100.0%
1
  33.3%
9
  60.0%
13
  61.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 15 participants 21 participants
Hispanic or Latino
0
   0.0%
1
  33.3%
0
   0.0%
1
   4.8%
Not Hispanic or Latino
3
 100.0%
2
  66.7%
15
 100.0%
20
  95.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 3 participants 3 participants 15 participants 21 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
3
 100.0%
3
 100.0%
14
  93.3%
20
  95.2%
Other
0
   0.0%
0
   0.0%
1
   6.7%
1
   4.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 3 participants 3 participants 15 participants 21 participants
Australia
1
  33.3%
1
  33.3%
4
  26.7%
6
  28.6%
France
0
   0.0%
0
   0.0%
1
   6.7%
1
   4.8%
Germany
0
   0.0%
0
   0.0%
1
   6.7%
1
   4.8%
United Kingdom
0
   0.0%
0
   0.0%
6
  40.0%
6
  28.6%
United States
2
  66.7%
2
  66.7%
3
  20.0%
7
  33.3%
1.Primary Outcome
Title Number of Participants With a Positive Anti-BMN 701 Antibody
Hide Description Status of Anti-BMN 701 antibody is corresponding to the test results of blood samples.
Time Frame Baseline, Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Please note the overall number of participants reflects the number of patients in that arm, while the outcome measurement number of participants reflects the number of patients for which data is available and analyzed.
Arm/Group Title BMN 701 5 mg/kg BMN 701 10 mg/kg BMN 701 20 mg/kg
Hide Arm/Group Description:
IV infusion at dose levels of 5 mg/kg
IV infusion at dose levels of 10 mg/kg
IV infusion at dose levels of 20 mg/kg
Overall Number of Participants Analyzed 3 3 15
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 2 participants 1 participants 12 participants
2
 100.0%
1
 100.0%
11
  91.7%
Week 144 Number Analyzed 2 participants 2 participants 10 participants
2
 100.0%
2
 100.0%
10
 100.0%
2.Primary Outcome
Title Number of Participants With a Positive Anti-BMN 701 Antibody Response
Hide Description Status of Anti-IGF-I antibody is corresponding to the test results of blood samples
Time Frame Baseline, Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title BMN 701 5 mg/kg BMN 701 10 mg/kg BMN 701 20 mg/kg
Hide Arm/Group Description:
IV infusion at dose levels of 5 mg/kg
IV infusion at dose levels of 10 mg/kg
IV infusion at dose levels of 20 mg/kg
Overall Number of Participants Analyzed 3 3 15
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 3 participants 3 participants 15 participants
0
   0.0%
2
  66.7%
0
   0.0%
Week 144 Number Analyzed 2 participants 2 participants 10 participants
0
   0.0%
1
  50.0%
5
  50.0%
3.Primary Outcome
Title Number of Participants With a Positive Anti-BMN 701 Antibody Response
Hide Description Status of Anti-IGF-II antibody is corresponding to the test results of blood samples
Time Frame Baseline, Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title BMN 701 5 mg/kg BMN 701 10 mg/kg BMN 701 20 mg/kg
Hide Arm/Group Description:
IV infusion at dose levels of 5 mg/kg
IV infusion at dose levels of 10 mg/kg
IV infusion at dose levels of 20 mg/kg
Overall Number of Participants Analyzed 3 3 15
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 3 participants 3 participants 15 participants
1
  33.3%
2
  66.7%
2
  13.3%
Week 144 Number Analyzed 2 participants 2 participants 10 participants
0
   0.0%
2
 100.0%
7
  70.0%
4.Secondary Outcome
Title Percent Predicted Maximal Inspiratory Pressure (MIP)
Hide Description Pulmonary Function Test: Percent Predicted Maximal Inspiratory Pressure
Time Frame Baseline, Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. No data collected for outcomes with 0 participants analyzed.
Arm/Group Title BMN 701 5 mg/kg BMN 701 10 mg/kg BMN 701 20 mg/kg
Hide Arm/Group Description:
IV infusion at dose levels of 5 mg/kg
IV infusion at dose levels of 10 mg/kg
IV infusion at dose levels of 20 mg/kg
Overall Number of Participants Analyzed 0 3 15
Mean (Standard Deviation)
Unit of Measure: Percent of Predicted
Baseline Number Analyzed 0 participants 3 participants 15 participants
39.53  (21.868) 40.2  (25.863)
Change from Baseline to Week 144 Number Analyzed 0 participants 2 participants 11 participants
21.17  (14.537) 18.48  (18.599)
5.Secondary Outcome
Title Percent Predicted Maximum Expiratory Pressure (MEP)
Hide Description Pulmonary Function Test: Percent Predicted Maximum Expiratory Pressure
Time Frame Baseline, Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. No data collected for outcomes with 0 participants analyzed.
Arm/Group Title BMN 701 5 mg/kg BMN 701 10 mg/kg BMN 701 20 mg/kg
Hide Arm/Group Description:
IV infusion at dose levels of 5 mg/kg
IV infusion at dose levels of 10 mg/kg
IV infusion at dose levels of 20 mg/kg
Overall Number of Participants Analyzed 0 3 15
Mean (Standard Deviation)
Unit of Measure: Percent of Predicted
Baseline Number Analyzed 0 participants 3 participants 15 participants
31.07  (6.641) 36.7  (15.939)
Change from Baseline to Week 144 Number Analyzed 0 participants 2 participants 11 participants
-0.28  (5.841) 5.11  (16.395)
6.Secondary Outcome
Title 6 Minutes Walk Test (Meters)
Hide Description Distance walked within 6 minutes
Time Frame Baseline, Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title BMN 701 5 mg/kg BMN 701 10 mg/kg BMN 701 20 mg/kg
Hide Arm/Group Description:
IV infusion at dose levels of 5 mg/kg
IV infusion at dose levels of 10 mg/kg
IV infusion at dose levels of 20 mg/kg
Overall Number of Participants Analyzed 3 3 15
Mean (Standard Deviation)
Unit of Measure: meter
Baseline Number Analyzed 3 participants 3 participants 15 participants
334  (227.119) 360  (51.403) 363.8  (157.818)
Change from Baseline to Week 144 Number Analyzed 3 participants 2 participants 11 participants
-36  (90.508) -120.75  (67.529) 9.5  (77.572)
7.Secondary Outcome
Title Maximum Voluntary Ventilation (MVV)
Hide Description Pulmonary function test: Maximum Voluntary Ventilation (MVV)
Time Frame Baseline, Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. No data collected for outcomes with 0 participants analyzed.
Arm/Group Title BMN 701 5 mg/kg BMN 701 10 mg/kg BMN 701 20 mg/kg
Hide Arm/Group Description:
IV infusion at dose levels of 5 mg/kg
IV infusion at dose levels of 10 mg/kg
IV infusion at dose levels of 20 mg/kg
Overall Number of Participants Analyzed 0 3 15
Mean (Standard Deviation)
Unit of Measure: L/min
Baseline Number Analyzed 0 participants 3 participants 15 participants
76  (41.037) 68.08  (26.74)
Change from Baseline to Week 144 Number Analyzed 0 participants 2 participants 11 participants
13.5  (13.435) 2.24  (11.635)
8.Secondary Outcome
Title Percent Predicted Upright Forced Vital Capacity (FVC)
Hide Description Pulmonary function test: Percent Predicted Upright Forced Vital Capacity
Time Frame Baseline, Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title BMN 701 5 mg/kg BMN 701 10 mg/kg BMN 701 20 mg/kg
Hide Arm/Group Description:
IV infusion at dose levels of 5 mg/kg
IV infusion at dose levels of 10 mg/kg
IV infusion at dose levels of 20 mg/kg
Overall Number of Participants Analyzed 3 3 15
Mean (Standard Deviation)
Unit of Measure: Percent Predicted
Baseline Number Analyzed 3 participants 3 participants 15 participants
69.33  (19.732) 67.33  (26.577) 57.13  (18.677)
Change from Baseline to Week 144 Number Analyzed 3 participants 2 participants 11 participants
-8.33  (7.095) -0.5  (4.95) -2  (8)
9.Secondary Outcome
Title Percent Predicted Upright Forced Vital Capacity (FVC)
Hide Description Pulmonary function test: Percent Predicted Upright Forced Vital capacity
Time Frame Baseline, Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title BMN 701 5 mg/kg BMN 701 10 mg/kg BMN 701 20 mg/kg
Hide Arm/Group Description:
IV infusion at dose levels of 5 mg/kg
IV infusion at dose levels of 10 mg/kg
IV infusion at dose levels of 20 mg/kg
Overall Number of Participants Analyzed 3 3 15
Mean (Standard Deviation)
Unit of Measure: Percent Predicted
Baseline Number Analyzed 3 participants 3 participants 12 participants
36.67  (17.954) 47.67  (32.578) 44.25  (21.55)
Change from Baseline to Week 144 Number Analyzed 3 participants 2 participants 7 participants
-4.33  (9.452) 4.5  (26.163) -3.43  (6.901)
10.Secondary Outcome
Title Change From Baseline in Urine Tetrasaccharide Concentration at Week 144
Hide Description Change from Baseline in Urine Tetrasaccharide Concentration at Week 144
Time Frame Baseline, Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. No data collected for outcomes with 0 participants analyzed.
Arm/Group Title BMN 701 5 mg/kg BMN 701 10 mg/kg BMN 701 20 mg/kg
Hide Arm/Group Description:
IV infusion at dose levels of 5 mg/kg
IV infusion at dose levels of 10 mg/kg
IV infusion at dose levels of 20 mg/kg
Overall Number of Participants Analyzed 0 2 10
Mean (Standard Deviation)
Unit of Measure: mmol/mol
-0.2  (3.394) -1.07  (0.975)
11.Secondary Outcome
Title Plasma IGF-I Concentration
Hide Description Plasma IGF-I concentration from lab
Time Frame Baseline, Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. No data collected for outcomes with 0 participants analyzed. Please note: the overall number of participants reflects the number of patients in that arm, while the outcome measurement number of participants reflects the number of patients for which data is available and analyzed.
Arm/Group Title BMN 701 5 mg/kg BMN 701 10 mg/kg BMN 701 20 mg/kg
Hide Arm/Group Description:
IV infusion at dose levels of 5 mg/kg
IV infusion at dose levels of 10 mg/kg
IV infusion at dose levels of 20 mg/kg
Overall Number of Participants Analyzed 2 2 15
Mean (Standard Deviation)
Unit of Measure: nmol/L
Baseline Number Analyzed 0 participants 0 participants 11 participants
20.26  (6.465)
Week 144 Number Analyzed 2 participants 2 participants 11 participants
26.98  (1.379) 18.4  (7.078) 17.62  (5.878)
12.Secondary Outcome
Title Plasma IGF-II Concentration
Hide Description Plasma IGF-II concentration from lab
Time Frame Baseline, Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. No data collected for outcomes with 0 participants analyzed. Please note: the overall number of participants reflects the number of patients in that arm, while the outcome measurement number of participants reflects the number of patients for which data is available and analyzed.
Arm/Group Title BMN 701 5 mg/kg BMN 701 10 mg/kg BMN 701 20 mg/kg
Hide Arm/Group Description:
IV infusion at dose levels of 5 mg/kg
IV infusion at dose levels of 10 mg/kg
IV infusion at dose levels of 20 mg/kg
Overall Number of Participants Analyzed 3 3 15
Mean (Standard Deviation)
Unit of Measure: nmol/L
Baseline Number Analyzed 0 participants 1 participants 6 participants
702  (0) 496.83  (113.417)
Week 144 Number Analyzed 3 participants 2 participants 11 participants
467.67  (117.142) 559.5  (140.714) 698.82  (228.948)
13.Secondary Outcome
Title Insulin-like Growth Factor Binding Protein 3 (IGFBP3)
Hide Description insulin-like growth factor binding protein 3 from lab
Time Frame Baseline, Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. No data collected for outcomes with 0 participants analyzed. Please note: the overall number of participants reflects the number of patients in that arm, while the outcome measurement number of participants reflects the number of patients for which data is available and analyzed.
Arm/Group Title BMN 701 5 mg/kg BMN 701 10 mg/kg BMN 701 20 mg/kg
Hide Arm/Group Description:
IV infusion at dose levels of 5 mg/kg
IV infusion at dose levels of 10 mg/kg
IV infusion at dose levels of 20 mg/kg
Overall Number of Participants Analyzed 3 2 15
Mean (Standard Deviation)
Unit of Measure: nmol/L
Baseline Number Analyzed 0 participants 0 participants 11 participants
150.45  (23.914)
Week 144 Number Analyzed 3 participants 2 participants 11 participants
157.33  (41.477) 209  (39.598) 146.64  (33.587)
Time Frame 284.9 weeks (maximum exposure) +4 weeks follow up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BMN 701 5 mg/kg BMN 701 10 mg/kg BMN 701 20 mg/kg Total
Hide Arm/Group Description BMN 701 5 mg/kg BMN 701 10 mg/kg BMN 701 20 mg/kg Total
All-Cause Mortality
BMN 701 5 mg/kg BMN 701 10 mg/kg BMN 701 20 mg/kg Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/3 (0.00%)      0/15 (0.00%)      0/21 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
BMN 701 5 mg/kg BMN 701 10 mg/kg BMN 701 20 mg/kg Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      1/3 (33.33%)      7/15 (46.67%)      10/21 (47.62%)    
Cardiac disorders         
Cardiac failure acute † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Myocardial infarction † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Gastrointestinal disorders         
Gastrooesophageal reflux disease † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
General disorders         
Fatigue † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Immune system disorders         
Anaphylactoid reaction † 1  1/3 (33.33%)  2 0/3 (0.00%)  0 0/15 (0.00%)  0 1/21 (4.76%)  2
Infections and infestations         
Pneumonia † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Injury, poisoning and procedural complications         
Fall † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Tendon rupture † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/15 (0.00%)  0 1/21 (4.76%)  1
Metabolism and nutrition disorders         
Hypoglycaemia † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Nervous system disorders         
Cerebrovascular accident † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Presyncope † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Renal and urinary disorders         
Prerenal failure † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Respiratory, thoracic and mediastinal disorders         
Chronic respiratory failure † 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/15 (0.00%)  0 1/21 (4.76%)  1
Respiratory failure † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/15 (0.00%)  0 1/21 (4.76%)  1
Stridor † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
1
Term from vocabulary, MedDRA 19.0
†
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BMN 701 5 mg/kg BMN 701 10 mg/kg BMN 701 20 mg/kg Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      3/3 (100.00%)      15/15 (100.00%)      21/21 (100.00%)    
Blood and lymphatic system disorders         
Anaemia † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Iron deficiency anaemia † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Cardiac disorders         
Bradycardia † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Cardiac failure † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Diastolic dysfunction † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Left ventricular hypertrophy † 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/15 (0.00%)  0 1/21 (4.76%)  1
Sinus tachycardia † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/15 (20.00%)  4 3/21 (14.29%)  4
Tachycardia † 1  1/3 (33.33%)  1 1/3 (33.33%)  1 5/15 (33.33%)  49 7/21 (33.33%)  51
Ear and labyrinth disorders         
Ear discomfort † 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/15 (0.00%)  0 1/21 (4.76%)  1
Tinnitus † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Vertigo positional † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/15 (0.00%)  0 1/21 (4.76%)  1
Endocrine disorders         
Androgen deficiency † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Eye disorders         
Blindness transient † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Ocular hyperaemia † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/15 (0.00%)  0 1/21 (4.76%)  1
Visual impairment † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Gastrointestinal disorders         
Abdominal discomfort † 1  1/3 (33.33%)  1 1/3 (33.33%)  1 1/15 (6.67%)  3 3/21 (14.29%)  5
Abdominal distension † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Abdominal pain † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/15 (13.33%)  3 2/21 (9.52%)  3
Abdominal pain lower † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Abdominal pain upper † 1  1/3 (33.33%)  1 1/3 (33.33%)  1 3/15 (20.00%)  5 5/21 (23.81%)  7
Abdominal tenderness † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/15 (0.00%)  0 1/21 (4.76%)  1
Constipation † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/15 (20.00%)  4 3/21 (14.29%)  4
Dental caries † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Diarrhoea † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 7/15 (46.67%)  13 7/21 (33.33%)  13
Dyspepsia † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/15 (0.00%)  0 1/21 (4.76%)  1
Flatulence † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Gastrooesophageal reflux disease † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/15 (20.00%)  3 3/21 (14.29%)  3
Irritable bowel syndrome † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/15 (13.33%)  3 2/21 (9.52%)  3
Nausea † 1  1/3 (33.33%)  1 1/3 (33.33%)  1 6/15 (40.00%)  29 8/21 (38.10%)  31
Painful defaecation † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Rectal haemorrhage † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Salivary hypersecretion † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/15 (13.33%)  2 2/21 (9.52%)  2
Tooth loss † 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/15 (0.00%)  0 1/21 (4.76%)  1
Toothache † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  5 1/21 (4.76%)  5
Vomiting † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/15 (20.00%)  4 3/21 (14.29%)  4
General disorders         
Application site erythema † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/15 (13.33%)  2 2/21 (9.52%)  2
Asthenia † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/15 (13.33%)  2 2/21 (9.52%)  2
Catheter site erythema † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Catheter site inflammation † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Catheter site pain † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/15 (13.33%)  2 2/21 (9.52%)  2
Chest discomfort † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 5/15 (33.33%)  19 6/21 (28.57%)  20
Chest pain † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Chills † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/15 (20.00%)  5 3/21 (14.29%)  5
Discomfort † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Extravasation † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Fatigue † 1  2/3 (66.67%)  18 0/3 (0.00%)  0 8/15 (53.33%)  16 10/21 (47.62%)  34
Feeling abnormal † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/15 (13.33%)  2 2/21 (9.52%)  2
Feeling cold † 1  0/3 (0.00%)  0 1/3 (33.33%)  1 2/15 (13.33%)  10 3/21 (14.29%)  11
Feeling hot † 1  0/3 (0.00%)  0 1/3 (33.33%)  1 3/15 (20.00%)  7 4/21 (19.05%)  8
Feeling of body temperature change † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Gait disturbance † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Influenza like illness † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Infusion site extravasation † 1  1/3 (33.33%)  2 0/3 (0.00%)  0 0/15 (0.00%)  0 1/21 (4.76%)  2
Infusion site pain † 1  2/3 (66.67%)  2 0/3 (0.00%)  0 0/15 (0.00%)  0 2/21 (9.52%)  2
Infusion site swelling † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/15 (0.00%)  0 1/21 (4.76%)  1
Malaise † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 4/15 (26.67%)  5 5/21 (23.81%)  6
Non-cardiac chest pain † 1  0/3 (0.00%)  0 1/3 (33.33%)  1 2/15 (13.33%)  2 3/21 (14.29%)  3
Oedema peripheral † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/15 (20.00%)  8 3/21 (14.29%)  8
Pain † 1  2/3 (66.67%)  2 0/3 (0.00%)  0 1/15 (6.67%)  2 3/21 (14.29%)  4
Peripheral swelling † 1  1/3 (33.33%)  1 1/3 (33.33%)  1 3/15 (20.00%)  3 5/21 (23.81%)  5
Pyrexia † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/15 (13.33%)  2 2/21 (9.52%)  2
Temperature intolerance † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Tenderness † 1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/15 (0.00%)  0 1/21 (4.76%)  2
Vessel puncture site bruise † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/15 (0.00%)  0 1/21 (4.76%)  1
Hepatobiliary disorders         
Cholelithiasis † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Immune system disorders         
Seasonal allergy † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  2 1/21 (4.76%)  2
Infections and infestations         
Blister infected † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Bronchitis † 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/15 (0.00%)  0 1/21 (4.76%)  1
Ear infection † 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/15 (0.00%)  0 1/21 (4.76%)  1
Fungal infection † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/15 (13.33%)  2 2/21 (9.52%)  2
Gastroenteritis viral † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Herpes simplex † 1  1/3 (33.33%)  3 0/3 (0.00%)  0 0/15 (0.00%)  0 1/21 (4.76%)  3
Influenza † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 3/15 (20.00%)  3 4/21 (19.05%)  4
Lower respiratory tract infection † 1  1/3 (33.33%)  1 1/3 (33.33%)  1 4/15 (26.67%)  9 6/21 (28.57%)  11
Lower respiratory tract infection viral † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/15 (13.33%)  2 2/21 (9.52%)  2
Nasopharyngitis † 1  0/3 (0.00%)  0 1/3 (33.33%)  1 4/15 (26.67%)  7 5/21 (23.81%)  8
Rhinitis † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 2/15 (13.33%)  2 3/21 (14.29%)  3
Sinusitis † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/15 (0.00%)  0 1/21 (4.76%)  1
Upper respiratory tract infection † 1  1/3 (33.33%)  3 2/3 (66.67%)  6 7/15 (46.67%)  11 10/21 (47.62%)  20
Urinary tract infection † 1  0/3 (0.00%)  0 1/3 (33.33%)  2 1/15 (6.67%)  1 2/21 (9.52%)  3
Viral infection † 1  0/3 (0.00%)  0 1/3 (33.33%)  2 1/15 (6.67%)  2 2/21 (9.52%)  4
Viral upper respiratory tract infection † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  2 1/21 (4.76%)  2
Injury, poisoning and procedural complications         
Contusion † 1  2/3 (66.67%)  5 1/3 (33.33%)  1 6/15 (40.00%)  9 9/21 (42.86%)  15
Epicondylitis † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/15 (0.00%)  0 1/21 (4.76%)  1
Eye contusion † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Fall † 1  3/3 (100.00%)  22 2/3 (66.67%)  5 7/15 (46.67%)  26 12/21 (57.14%)  53
Head injury † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Joint injury † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Laceration † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/15 (6.67%)  1 2/21 (9.52%)  2
Muscle contusion † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/15 (0.00%)  0 1/21 (4.76%)  1
Muscle strain † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/15 (6.67%)  1 2/21 (9.52%)  2
Post procedural contusion † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Post procedural haemorrhage † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Procedural pain † 1  1/3 (33.33%)  2 0/3 (0.00%)  0 2/15 (13.33%)  2 3/21 (14.29%)  4
Skin abrasion † 1  2/3 (66.67%)  5 1/3 (33.33%)  1 1/15 (6.67%)  1 4/21 (19.05%)  7
Skin wound † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Tendon injury † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/15 (0.00%)  0 1/21 (4.76%)  1
Thermal burn † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Tooth fracture † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  3 1/21 (4.76%)  3
Wound † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Investigations         
Ammonia increased † 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/15 (0.00%)  0 1/21 (4.76%)  1
Bacterial test positive † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  2 1/21 (4.76%)  2
Blood calcium decreased † 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/15 (0.00%)  0 1/21 (4.76%)  1
Blood glucose decreased † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 7/15 (46.67%)  14 7/21 (33.33%)  14
Blood immunoglobulin E increased † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Cardiac murmur † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/15 (6.67%)  1 2/21 (9.52%)  2
Complement factor increased † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Lipase increased † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Pulmonary physical examination abnormal † 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/15 (0.00%)  0 1/21 (4.76%)  1
Troponin increased † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Tryptase increased † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Metabolism and nutrition disorders         
Dehydration † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  2 1/21 (4.76%)  2
Glucose tolerance impaired † 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/15 (0.00%)  0 1/21 (4.76%)  1
Hyperglycaemia † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  2 1/21 (4.76%)  2
Hyperkalaemia † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Hypoglycaemia † 1  1/3 (33.33%)  19 1/3 (33.33%)  30 14/15 (93.33%)  106 16/21 (76.19%)  155
Iron deficiency † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Musculoskeletal and connective tissue disorders         
Arthralgia † 1  2/3 (66.67%)  8 1/3 (33.33%)  1 7/15 (46.67%)  18 10/21 (47.62%)  27
Back pain † 1  3/3 (100.00%)  6 1/3 (33.33%)  1 7/15 (46.67%)  10 11/21 (52.38%)  17
Bursitis † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Flank pain † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/15 (13.33%)  2 2/21 (9.52%)  2
Groin pain † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Intervertebral disc protrusion † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Joint swelling † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Muscle spasms † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 3/15 (20.00%)  9 4/21 (19.05%)  10
Muscle twitching † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Muscular weakness † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 2/15 (13.33%)  2 3/21 (14.29%)  3
Musculoskeletal chest pain † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/15 (6.67%)  1 2/21 (9.52%)  2
Musculoskeletal discomfort † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Musculoskeletal pain † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 2/15 (13.33%)  3 3/21 (14.29%)  4
Myalgia † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/15 (20.00%)  4 3/21 (14.29%)  4
Neck pain † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/15 (20.00%)  4 3/21 (14.29%)  4
Osteopenia † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Pain in extremity † 1  1/3 (33.33%)  1 1/3 (33.33%)  1 8/15 (53.33%)  14 10/21 (47.62%)  16
Spinal pain † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Tendonitis † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Skin papilloma † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Nervous system disorders         
Balance disorder † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Burning sensation † 1  0/3 (0.00%)  0 1/3 (33.33%)  1 2/15 (13.33%)  2 3/21 (14.29%)  3
Dizziness † 1  1/3 (33.33%)  1 1/3 (33.33%)  5 8/15 (53.33%)  11 10/21 (47.62%)  17
Headache † 1  2/3 (66.67%)  7 1/3 (33.33%)  4 9/15 (60.00%)  30 12/21 (57.14%)  41
Hypoaesthesia † 1  1/3 (33.33%)  1 1/3 (33.33%)  1 3/15 (20.00%)  3 5/21 (23.81%)  5
Lethargy † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Migraine † 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/15 (0.00%)  0 1/21 (4.76%)  1
Paraesthesia † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  2 1/21 (4.76%)  2
Presyncope † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Restless legs syndrome † 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/15 (0.00%)  0 1/21 (4.76%)  1
Sciatica † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/15 (0.00%)  0 1/21 (4.76%)  1
Sinus headache † 1  1/3 (33.33%)  2 0/3 (0.00%)  0 0/15 (0.00%)  0 1/21 (4.76%)  2
Tremor † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/15 (13.33%)  2 2/21 (9.52%)  2
Tunnel vision † 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/15 (0.00%)  0 1/21 (4.76%)  1
Product Issues         
Device occlusion † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Psychiatric disorders         
Anxiety † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  2 1/21 (4.76%)  2
Confusional state † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Insomnia † 1  1/3 (33.33%)  2 1/3 (33.33%)  1 2/15 (13.33%)  2 4/21 (19.05%)  5
Mood swings † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Nervousness † 1  1/3 (33.33%)  4 1/3 (33.33%)  1 4/15 (26.67%)  6 6/21 (28.57%)  11
Restlessness † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 2/15 (13.33%)  2 3/21 (14.29%)  3
Sleep terror † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Renal and urinary disorders         
Haematuria † 1  0/3 (0.00%)  0 1/3 (33.33%)  1 2/15 (13.33%)  2 3/21 (14.29%)  3
Renal impairment † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Respiratory, thoracic and mediastinal disorders         
Asthma † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Chronic respiratory failure † 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/15 (0.00%)  0 1/21 (4.76%)  1
Cough † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/15 (20.00%)  8 3/21 (14.29%)  8
Dyspnoea † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 9/15 (60.00%)  26 10/21 (47.62%)  27
Epistaxis † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  2 1/21 (4.76%)  2
Hypoxia † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  2 1/21 (4.76%)  2
Nasal congestion † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/15 (13.33%)  2 2/21 (9.52%)  2
Oropharyngeal pain † 1  1/3 (33.33%)  1 1/3 (33.33%)  2 5/15 (33.33%)  12 7/21 (33.33%)  15
Paranasal sinus hypersecretion † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Pleuritic pain † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/15 (13.33%)  2 2/21 (9.52%)  2
Productive cough † 1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/15 (0.00%)  0 1/21 (4.76%)  2
Pulmonary congestion † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Rales † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Respiratory failure † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/15 (6.67%)  1 2/21 (9.52%)  2
Tachypnoea † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  40 1/21 (4.76%)  40
Wheezing † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  4 1/21 (4.76%)  4
Skin and subcutaneous tissue disorders         
Angioedema † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/15 (6.67%)  1 2/21 (9.52%)  2
Cold sweat † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/15 (20.00%)  3 3/21 (14.29%)  3
Decubitus ulcer † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Dermal cyst † 1  1/3 (33.33%)  4 0/3 (0.00%)  0 0/15 (0.00%)  0 1/21 (4.76%)  4
Erythema † 1  1/3 (33.33%)  1 1/3 (33.33%)  1 3/15 (20.00%)  4 5/21 (23.81%)  6
Hyperhidrosis † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 4/15 (26.67%)  14 4/21 (19.05%)  14
Night sweats † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Pruritus † 1  1/3 (33.33%)  2 0/3 (0.00%)  0 2/15 (13.33%)  3 3/21 (14.29%)  5
Rash † 1  1/3 (33.33%)  1 2/3 (66.67%)  5 1/15 (6.67%)  1 4/21 (19.05%)  7
Rash macular † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Rash papular † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/15 (0.00%)  0 1/21 (4.76%)  1
Rash pruritic † 1  1/3 (33.33%)  2 1/3 (33.33%)  1 0/15 (0.00%)  0 2/21 (9.52%)  3
Rosacea † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/15 (0.00%)  0 1/21 (4.76%)  1
Skin lesion † 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/15 (0.00%)  0 1/21 (4.76%)  1
Skin mass † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Skin ulcer † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  1 1/21 (4.76%)  1
Urticaria † 1  3/3 (100.00%)  8 1/3 (33.33%)  1 2/15 (13.33%)  3 6/21 (28.57%)  12
Vascular disorders         
Flushing † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 4/15 (26.67%)  8 4/21 (19.05%)  8
Haematoma † 1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/15 (6.67%)  1 2/21 (9.52%)  2
Hot flush † 1  1/3 (33.33%)  1 1/3 (33.33%)  1 4/15 (26.67%)  4 6/21 (28.57%)  6
Hypertension † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/15 (20.00%)  6 3/21 (14.29%)  6
Hypotension † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/15 (20.00%)  6 3/21 (14.29%)  6
Pallor † 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/15 (6.67%)  3 1/21 (4.76%)  3
1
Term from vocabulary, MedDRA 19.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Debra Lounsbury, Principal Scientist, Clinical Sciences
Organization: BioMarin Pharmaceutical Inc.
Phone: 415-506-6348
EMail: DLounsbury@bmrn.com
Layout table for additonal information
Responsible Party: BioMarin Pharmaceutical
ClinicalTrials.gov Identifier: NCT01435772     History of Changes
Other Study ID Numbers: POM-002
2011-001805-28 ( EudraCT Number )
First Submitted: September 8, 2011
First Posted: September 19, 2011
Results First Submitted: September 12, 2017
Results First Posted: May 22, 2018
Last Update Posted: May 22, 2018