ClinicalTrials.gov
ClinicalTrials.gov Menu

Long-Term Efficacy and Safety Extension Study of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome)

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: NCT01415427
Recruitment Status : Completed
First Posted : August 12, 2011
Results First Posted : May 19, 2017
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
BioMarin Pharmaceutical

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Mucopolysaccharidosis IV A
Morquio A Syndrome
MPS IVA
Interventions Drug: BMN 110 - Weekly
Drug: BMN 110 - Every Other Week
Enrollment 173
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PBO-QOW PBO-QW QOW-QOW QW-QW
Hide Arm/Group Description Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005 Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005 Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005 Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
Period Title: Overall Study
Started 29 29 59 56
Completed 0 0 1 0
Not Completed 29 29 58 56
Arm/Group Title PBO-QOW PBO-QW QOW-QOW QW-QW Total
Hide Arm/Group Description Placebo in MOR004 + BMN110 2.0 mg/kg/qow in MOR005 Placebo in MOR004 + BMN110 2.0 mg/kg/qw in MOR005 BMN110 2.0 mg/kg/qow in MOR004 + BMN110 2.0 mg/kg/qow in MOR005 BMN110 2.0 mg/kg/qw in MOR004 + BMN110 2.0 mg/kg/qw in MOR005 Total of all reporting groups
Overall Number of Baseline Participants 29 29 59 56 173
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 29 participants 59 participants 56 participants 173 participants
16.7  (13.66) 13.5  (8.50) 15.3  (10.79) 12.8  (8.01) 14.4  (10.20)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 59 participants 56 participants 173 participants
5 - 11 15 15 31 32 93
12 - 18 7 7 16 16 46
>=19 7 7 12 8 34
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 59 participants 56 participants 173 participants
Female
14
  48.3%
18
  62.1%
25
  42.4%
30
  53.6%
87
  50.3%
Male
15
  51.7%
11
  37.9%
34
  57.6%
26
  46.4%
86
  49.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 59 participants 56 participants 173 participants
Hispanic or Latino
4
  13.8%
8
  27.6%
16
  27.1%
9
  16.1%
37
  21.4%
Not Hispanic or Latino
25
  86.2%
21
  72.4%
43
  72.9%
47
  83.9%
136
  78.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 59 participants 56 participants 173 participants
American Indian or Alaska Native 0 0 0 0 0
Asian 4 7 15 14 40
Native Hawaiian or Other Pacific Islander 0 0 0 0 0
Black or African American 0 0 2 2 4
White 25 18 35 35 113
Other 0 4 7 5 16
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 59 participants 56 participants 173 participants
Argentina 0 1 1 0 2
Brazil 2 3 10 5 20
Canada 3 1 5 5 14
Colombia 0 2 2 2 6
Denmark 0 0 0 1 1
France 2 5 5 8 20
Germany 2 2 5 1 10
Italy 3 1 4 2 10
Japan 0 0 4 2 6
Korea, South 2 1 1 3 7
Netherlands 1 0 2 3 6
Portugal 1 1 1 0 3
Qatar 0 1 0 1 2
Saudi Arabia 0 2 1 4 7
Taiwan 0 1 3 1 5
United Kingdom 6 3 4 9 22
United States 7 5 11 9 32
1.Primary Outcome
Title Change From Baseline in 6-minute Walk (6MW) Test - ITT
Hide Description Efficacy was assessed by changes from baseline in 6-minute walk test
Time Frame Baseline to week 168
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-intent-to-treat population, defined as all patients enrolled in the study who received patient IDs regardless of whether they received study drug or not.
Arm/Group Title PBO-QOW PBO-QW QOW-QOW QW-QW Total
Hide Arm/Group Description:
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
All treatment groups
Overall Number of Participants Analyzed 29 29 59 58 176
Mean (Standard Deviation)
Unit of Measure: meters
Baseline Number Analyzed 29 participants 29 participants 59 participants 58 participants 176 participants
219.7  (74.22) 207.2  (64.87) 205.7  (81.19) 203.9  (76.32) 207.2  (75.58)
Change from Baseline to Week 24 Number Analyzed 29 participants 29 participants 59 participants 57 participants 175 participants
23.8  (56.21) 5.0  (43.27) 11.1  (49.95) 36.5  (58.49) 20.2  (54.02)
Change from Baseline to Week 72 Number Analyzed 28 participants 27 participants 57 participants 55 participants 167 participants
41.5  (89.24) -1.5  (112.07) 27.2  (56.66) 30.6  (73.66) 26.1  (79.26)
Change from Baseline to Week 120 Number Analyzed 28 participants 27 participants 54 participants 54 participants 163 participants
32.3  (92.13) -2.9  (95.69) 6.0  (86.28) 29.7  (81.37) 16.9  (87.67)
Change from Baseline to Week 168 Number Analyzed 10 participants 13 participants 32 participants 26 participants 81 participants
52.2  (100.07) 20.1  (80.79) 5.2  (81.54) -8.8  (101.24) 8.9  (90.81)
2.Primary Outcome
Title Change From Baseline in 6-minute Walk (6MW) Test - MPP
Hide Description Efficacy was assessed by changes from baseline in 6-minute walk test
Time Frame Baseline to week 168
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
MPP- modified per-protocol population, define as the ITT(intent to treat) after removing patients who had orthosurgery in first 120 weeks or <96 doses in first 120 weeks.
Arm/Group Title PBO-QOW PBO-QW QOW-QOW QW-QW Total
Hide Arm/Group Description:
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
All treatment groups
Overall Number of Participants Analyzed 20 19 42 43 124
Mean (Standard Deviation)
Unit of Measure: meters
Baseline Number Analyzed 20 participants 19 participants 42 participants 43 participants 124 participants
208.7  (78.12) 190.2  (65.54) 195.9  (80.40) 208.8  (73.24) 201.6  (74.94)
Change from Baseline to Week 24 Number Analyzed 20 participants 19 participants 42 participants 43 participants 124 participants
30.3  (56.53) 9.6  (46.87) 13.6  (52.65) 41.5  (59.89) 25.4  (56.08)
Change from Baseline to Week 72 Number Analyzed 20 participants 18 participants 42 participants 43 participants 123 participants
54.5  (85.19) 37.7  (69.35) 35.3  (58.19) 37.5  (72.17) 39.6  (69.11)
Change from Baseline to Week 120 Number Analyzed 20 participants 19 participants 41 participants 43 participants 123 participants
60.8  (64.45) 19.8  (86.69) 19.7  (77.29) 38.6  (66.65) 33.0  (73.94)
Change from Baseline to Week 168 Number Analyzed 5 participants 8 participants 26 participants 22 participants 61 participants
85.8  (128.04) 14.6  (94.41) 10.0  (84.66) -12.3  (106.34) 8.8  (98.69)
3.Secondary Outcome
Title Change From Baseline in 3-minute Stair Climb Test - ITT
Hide Description Efficacy was assessed by changes from baseline in 3-minute stair climb test.
Time Frame Baseline to week 168
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-intent-to-treat population, defined as all patients enrolled in the study who received patient IDs regardless of whether they received study drug or not
Arm/Group Title PBO-QOW PBO-QW QOW-QOW QW-QW Total
Hide Arm/Group Description:
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
All treatment groups
Overall Number of Participants Analyzed 29 29 59 58 176
Mean (Standard Deviation)
Unit of Measure: stairs/min
Baseline Number Analyzed 29 participants 29 participants 59 participants 58 participants 176 participants
33.1  (15.60) 26.9  (12.08) 27.1  (15.80) 29.6  (16.44) 28.9  (15.42)
Change from Baseline to Week 24 Number Analyzed 29 participants 29 participants 59 participants 57 participants 175 participants
4.7  (9.65) 2.9  (7.30) 2.9  (10.94) 4.8  (8.06) 3.8  (9.25)
Change from Baseline to Week 72 Number Analyzed 28 participants 26 participants 56 participants 54 participants 164 participants
8.9  (15.44) 1.2  (14.95) 5.5  (11.96) 5.3  (9.88) 5.3  (12.60)
Change from Baseline to Week 120 Number Analyzed 28 participants 27 participants 54 participants 53 participants 162 participants
6.0  (17.05) 1.7  (14.80) 4.7  (14.60) 5.8  (13.42) 4.8  (14.65)
Change from baseline to week 168 Number Analyzed 10 participants 13 participants 32 participants 25 participants 80 participants
8.9  (17.57) 5.5  (15.44) 4.6  (13.64) 0.4  (20.96) 4.0  (16.90)
4.Secondary Outcome
Title Change From Baseline in 3-minute Stair Climb Test - MPP
Hide Description Efficacy was assessed by changes from baseline in 3-minute stair climb test.
Time Frame Baseline to week 168
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
MPP- modified per-protocol population, define as the ITT(intent to treat) after removing patients who had orthosurgery in first 120 weeks or <96 doses in first 120 weeks
Arm/Group Title PBO-QOW PBO-QW QOW-QOW QW-QW Total
Hide Arm/Group Description:
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
All treatment groups
Overall Number of Participants Analyzed 20 19 42 43 124
Mean (Standard Deviation)
Unit of Measure: stairs/min
Baseline Number Analyzed 20 participants 19 participants 42 participants 43 participants 124 participants
33.1  (14.12) 24.8  (13.92) 25.6  (13.73) 31.3  (16.22) 28.7  (14.93)
Change from Baseline to Week 24 Number Analyzed 20 participants 19 participants 42 participants 43 participants 124 participants
3.4  (8.09) 3.6  (8.63) 5.0  (11.46) 3.9  (7.67) 4.1  (9.23)
Change from Baseline to Week 72 Number Analyzed 20 participants 18 participants 42 participants 43 participants 123 participants
10.4  (13.77) 6.1  (10.56) 7.4  (12.53) 5.7  (9.98) 7.1  (11.61)
Change from Baseline to Week 120 Number Analyzed 20 participants 19 participants 41 participants 42 participants 122 participants
9.1  (13.38) 4.2  (12.49) 8.1  (13.83) 7.2  (12.58) 7.4  (13.05)
Change from baseline to week 168 Number Analyzed 5 participants 8 participants 26 participants 21 participants 60 participants
12.4  (23.03) 4.3  (17.82) 6.0  (14.59) -2.6  (18.47) 3.3  (17.39)
5.Secondary Outcome
Title Change From Baseline in Urine Keratan Sulfate - ITT
Hide Description Efficacy was assessed by changes from baseline in urine keratan sulfate (normalized to urine creatinine.)
Time Frame Baseline to week 168
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-intent-to-treat population, defined as all patients enrolled in the study who received patient IDs regardless of whether they received study drug or not
Arm/Group Title PBO-QOW PBO-QW QOW-QOW QW-QW Total
Hide Arm/Group Description:
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
All treatment groups
Overall Number of Participants Analyzed 29 29 59 58 176
Mean (Standard Deviation)
Unit of Measure: ug/mg
Baseline Number Analyzed 28 participants 29 participants 59 participants 58 participants 176 participants
22.7  (15.27) 28.5  (14.89) 28.6  (21.17) 26.9  (14.11) 27.1  (17.05)
Percent Change from Baseline to Week 24 Number Analyzed 26 participants 28 participants 57 participants 54 participants 166 participants
3.4  (29.15) -11.3  (23.68) -35.2  (20.70) -45.1  (19.89) -28.2  (28.46)
Percent Change from Baseline to Week 72 Number Analyzed 26 participants 28 participants 57 participants 51 participants 162 participants
-54.1  (17.21) -56.8  (13.69) -55.6  (14.23) -53.7  (17.45) -55.0  (15.61)
Percent Change from Baseline to Week 120 Number Analyzed 26 participants 24 participants 53 participants 53 participants 156 participants
-55.5  (18.60) -62.2  (15.39) -55.8  (26.56) -61.5  (20.59) -58.7  (21.88)
Percent Change from Baseline to Week 168 Number Analyzed 8 participants 11 participants 27 participants 18 participants 64 participants
-31.9  (31.20) -38.3  (47.43) -28.5  (35.14) -39.3  (47.39) -33.7  (40.06)
6.Secondary Outcome
Title Change From Baseline in Urine Keratan Sulfate - MPP
Hide Description Efficacy was assessed by changes from baseline in urine keratan sulfate (normalized to urine creatinine.)
Time Frame Baseline to week 168
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
MPP- modified per-protocol population, define as the ITT(intent to treat) after removing patients who had orthosurgery in first 120 weeks or <96 doses in first 120 weeks
Arm/Group Title PBO-QOW PBO-QW QOW-QOW QW-QW Total
Hide Arm/Group Description:
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
All treatment groups
Overall Number of Participants Analyzed 20 19 42 43 124
Mean (Standard Deviation)
Unit of Measure: ug/mg
Baseline Number Analyzed 19 participants 19 participants 42 participants 43 participants 123 participants
21.2  (15.55) 27.5  (15.24) 27.2  (22.90) 24.9  (13.13) 25.5  (17.61)
Percent Change from Baseline to Week 24 Number Analyzed 17 participants 19 participants 41 participants 40 participants 117 participants
1.2  (24.34) -12.9  (24.29) -35.5  (22.62) -44.9  (19.60) -29.7  (27.52)
Percent Change from Baseline to Week 72 Number Analyzed 18 participants 19 participants 41 participants 41 participants 119 participants
-51.7  (19.34) -58.8  (14.60) -56.9  (13.55) -53.7  (17.87) -55.3  (16.21)
Percent Change from Baseline to Week 120 Number Analyzed 18 participants 17 participants 40 participants 42 participants 117 participants
-58.3  (15.87) -64.2  (16.58) -62.1  (15.97) -61.8  (21.28) -61.7  (17.98)
Percent Change from Baseline to Week 168 Number Analyzed 4 participants 7 participants 22 participants 15 participants 48 participants
-9.9  (23.48) -41.6  (46.05) -27.1  (37.28) -43.0  (34.07) -32.8  (37.11)
Time Frame Study Period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PBO-QOW PBO-QW QOW-QOW QW-QW Total
Hide Arm/Group Description PBO-QOW PBO-QW QOW-QOW QW-QW Total
All-Cause Mortality
PBO-QOW PBO-QW QOW-QOW QW-QW Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)      0/29 (0.00%)      1/59 (1.69%)      0/56 (0.00%)      1/173 (0.58%)    
Show Serious Adverse Events Hide Serious Adverse Events
PBO-QOW PBO-QW QOW-QOW QW-QW Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/29 (58.62%)      15/29 (51.72%)      26/59 (44.07%)      31/56 (55.36%)      89/173 (51.45%)    
Cardiac disorders           
Cardio-respiratory arrest  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 1/173 (0.58%)  1
Congenital, familial and genetic disorders           
Congenital osteodystrophy  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 1/56 (1.79%)  2 1/173 (0.58%)  2
Developmental hip dysplasia  1  1/29 (3.45%)  1 0/29 (0.00%)  0 1/59 (1.69%)  1 1/56 (1.79%)  1 3/173 (1.73%)  3
Ear and labyrinth disorders           
Deafness  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/59 (0.00%)  0 0/56 (0.00%)  0 1/173 (0.58%)  1
Middle ear effusion  1  1/29 (3.45%)  1 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 2/173 (1.16%)  2
Eye disorders           
Strabismus  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/59 (0.00%)  0 0/56 (0.00%)  0 1/173 (0.58%)  1
Gastrointestinal disorders           
Abdominal pain  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 1/56 (1.79%)  1 1/173 (0.58%)  1
Dyspepsia  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/59 (0.00%)  0 0/56 (0.00%)  0 1/173 (0.58%)  1
Inguinal hernia  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 1/173 (0.58%)  1
Oesophageal spasm  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/59 (0.00%)  0 0/56 (0.00%)  0 1/173 (0.58%)  1
Rectal haemorrhage  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 1/173 (0.58%)  1
Vomiting  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 3/56 (5.36%)  5 4/173 (2.31%)  6
General disorders           
Device dislocation  1  0/29 (0.00%)  0 1/29 (3.45%)  1 1/59 (1.69%)  1 1/56 (1.79%)  1 3/173 (1.73%)  3
Device occlusion  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 1/173 (0.58%)  1
Pyrexia  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 1/173 (0.58%)  1
Immune system disorders           
Anaphylactic reaction  1  1/29 (3.45%)  1 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 2/173 (1.16%)  2
Hypersensitivity  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 1/56 (1.79%)  1 1/173 (0.58%)  1
Infections and infestations           
Appendicitis  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 1/56 (1.79%)  1 1/173 (0.58%)  1
Dengue fever  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 1/173 (0.58%)  1
Diverticulitis  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 1/173 (0.58%)  1
Gastroenteritis  1  1/29 (3.45%)  1 0/29 (0.00%)  0 2/59 (3.39%)  2 0/56 (0.00%)  0 3/173 (1.73%)  3
Infected cyst  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 1/56 (1.79%)  2 1/173 (0.58%)  2
Influenza  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 1/56 (1.79%)  1 1/173 (0.58%)  1
Lower respiratory tract infection  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/59 (0.00%)  0 3/56 (5.36%)  3 4/173 (2.31%)  4
Mononucleosis syndrome  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/59 (0.00%)  0 0/56 (0.00%)  0 1/173 (0.58%)  1
Otitis media  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  3 1/56 (1.79%)  1 2/173 (1.16%)  4
Otitis media chronic  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/59 (0.00%)  0 0/56 (0.00%)  0 1/173 (0.58%)  1
Pilonidal cyst  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 1/56 (1.79%)  1 1/173 (0.58%)  1
Pneumonia  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 3/56 (5.36%)  3 3/173 (1.73%)  3
Tooth abscess  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 1/173 (0.58%)  1
Viral upper respiratory tract infection  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 1/56 (1.79%)  1 1/173 (0.58%)  1
Injury, poisoning and procedural complications           
Fall  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/59 (0.00%)  0 0/56 (0.00%)  0 1/173 (0.58%)  1
Joint dislocation  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 1/173 (0.58%)  1
Lower limb fracture  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/59 (0.00%)  0 0/56 (0.00%)  0 1/173 (0.58%)  1
Procedural pain  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 1/56 (1.79%)  1 1/173 (0.58%)  1
Pseudomeningocele  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 1/56 (1.79%)  1 1/173 (0.58%)  1
Musculoskeletal and connective tissue disorders           
Arthralgia  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 1/173 (0.58%)  1
Back pain  1  0/29 (0.00%)  0 0/29 (0.00%)  0 2/59 (3.39%)  2 0/56 (0.00%)  0 2/173 (1.16%)  2
Joint instability  1  2/29 (6.90%)  2 0/29 (0.00%)  0 1/59 (1.69%)  1 2/56 (3.57%)  2 5/173 (2.89%)  5
Knee deformity  1  6/29 (20.69%)  8 8/29 (27.59%)  9 7/59 (11.86%)  7 8/56 (14.29%)  8 29/173 (16.76%)  32
Limb deformity  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 1/56 (1.79%)  1 1/173 (0.58%)  1
Osteoarthritis  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/59 (0.00%)  0 0/56 (0.00%)  0 1/173 (0.58%)  1
Osteochondrosis  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 1/173 (0.58%)  1
Nervous system disorders           
Cervical cord compression  1  1/29 (3.45%)  1 1/29 (3.45%)  1 0/59 (0.00%)  0 1/56 (1.79%)  1 3/173 (1.73%)  3
Cervical myelopathy  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/59 (0.00%)  0 0/56 (0.00%)  0 1/173 (0.58%)  1
Convulsion  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/59 (0.00%)  0 0/56 (0.00%)  0 1/173 (0.58%)  1
Myelopathy  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 1/173 (0.58%)  1
Paraplegia  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 1/56 (1.79%)  1 1/173 (0.58%)  1
Quadriplegia  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/59 (0.00%)  0 0/56 (0.00%)  0 1/173 (0.58%)  1
Spinal cord compression  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/59 (0.00%)  0 3/56 (5.36%)  3 4/173 (2.31%)  4
Spinal cord ischaemia  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 1/173 (0.58%)  1
Pregnancy, puerperium and perinatal conditions           
Blighted ovum  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 1/56 (1.79%)  1 1/173 (0.58%)  1
Ectopic pregnancy  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 1/56 (1.79%)  1 1/173 (0.58%)  1
Psychiatric disorders           
Somatoform disorder  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  2 0/56 (0.00%)  0 1/173 (0.58%)  2
Renal and urinary disorders           
Haematuria  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/59 (0.00%)  0 0/56 (0.00%)  0 1/173 (0.58%)  1
Respiratory, thoracic and mediastinal disorders           
Asthma  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 1/56 (1.79%)  1 2/173 (1.16%)  2
Bronchopneumopathy  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 1/173 (0.58%)  1
Bronchospasm  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 1/56 (1.79%)  1 1/173 (0.58%)  1
Lung disorder  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 1/173 (0.58%)  1
Sleep apnoea syndrome  1  0/29 (0.00%)  0 1/29 (3.45%)  1 1/59 (1.69%)  1 0/56 (0.00%)  0 2/173 (1.16%)  2
Status asthmaticus  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 1/56 (1.79%)  1 1/173 (0.58%)  1
Tonsillar hypertrophy  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/59 (0.00%)  0 1/56 (1.79%)  1 2/173 (1.16%)  2
Tracheal disorder  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/59 (0.00%)  0 0/56 (0.00%)  0 1/173 (0.58%)  1
Tracheal stenosis  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 1/173 (0.58%)  1
Skin and subcutaneous tissue disorders           
Skin ulcer  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 1/173 (0.58%)  1
Urticaria  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 1/56 (1.79%)  1 1/173 (0.58%)  1
Social circumstances           
Child abuse  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 1/173 (0.58%)  1
Surgical and medical procedures           
Central venous catheterisation  1  1/29 (3.45%)  1 0/29 (0.00%)  0 3/59 (5.08%)  3 1/56 (1.79%)  1 5/173 (2.89%)  5
Epiphyseal stapling  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/59 (0.00%)  0 0/56 (0.00%)  0 1/173 (0.58%)  1
Knee operation  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/59 (0.00%)  0 0/56 (0.00%)  0 1/173 (0.58%)  1
Medical device implantation  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 1/56 (1.79%)  1 2/173 (1.16%)  2
Medical device removal  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/59 (0.00%)  0 4/56 (7.14%)  4 5/173 (2.89%)  5
Spinal decompression  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 1/173 (0.58%)  1
Vascular disorders           
Poor venous access  1  0/29 (0.00%)  0 2/29 (6.90%)  2 5/59 (8.47%)  5 5/56 (8.93%)  5 12/173 (6.94%)  12
1
Term from vocabulary, MedDRA 16.1
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%
PBO-QOW PBO-QW QOW-QOW QW-QW Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/29 (100.00%)      29/29 (100.00%)      59/59 (100.00%)      56/56 (100.00%)      173/173 (100.00%)    
Blood and lymphatic system disorders           
Lymphadenopathy  1  3/29 (10.34%)  4 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 4/173 (2.31%)  5
Cardiac disorders           
Aortic valve disease  1  1/29 (3.45%)  1 1/29 (3.45%)  1 5/59 (8.47%)  5 2/56 (3.57%)  2 9/173 (5.20%)  9
Aortic valve incompetence  1  1/29 (3.45%)  1 3/29 (10.34%)  3 8/59 (13.56%)  8 4/56 (7.14%)  4 16/173 (9.25%)  16
Left ventricular hypertrophy  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1 4/56 (7.14%)  4 5/173 (2.89%)  5
Mitral valve disease  1  1/29 (3.45%)  1 1/29 (3.45%)  1 6/59 (10.17%)  6 3/56 (5.36%)  4 11/173 (6.36%)  12
Mitral valve incompetence  1  4/29 (13.79%)  4 6/29 (20.69%)  6 12/59 (20.34%)  12 4/56 (7.14%)  5 26/173 (15.03%)  27
Palpitations  1  1/29 (3.45%)  1 2/29 (6.90%)  4 1/59 (1.69%)  1 2/56 (3.57%)  2 6/173 (3.47%)  8
Pulmonary valve incompetence  1  2/29 (6.90%)  2 3/29 (10.34%)  3 2/59 (3.39%)  2 5/56 (8.93%)  5 12/173 (6.94%)  12
Sinus arrhythmia  1  0/29 (0.00%)  0 0/29 (0.00%)  0 3/59 (5.08%)  3 1/56 (1.79%)  1 4/173 (2.31%)  4
Sinus tachycardia  1  1/29 (3.45%)  1 3/29 (10.34%)  4 1/59 (1.69%)  1 1/56 (1.79%)  11 6/173 (3.47%)  17
Tachycardia  1  8/29 (27.59%)  14 4/29 (13.79%)  15 8/59 (13.56%)  31 11/56 (19.64%)  29 31/173 (17.92%)  89
Tricuspid valve incompetence  1  6/29 (20.69%)  6 1/29 (3.45%)  1 11/59 (18.64%)  12 7/56 (12.50%)  8 25/173 (14.45%)  27
Ear and labyrinth disorders           
Ear discomfort  1  2/29 (6.90%)  3 0/29 (0.00%)  0 1/59 (1.69%)  1 2/56 (3.57%)  6 5/173 (2.89%)  10
Ear pain  1  10/29 (34.48%)  16 7/29 (24.14%)  8 19/59 (32.20%)  42 19/56 (33.93%)  26 55/173 (31.79%)  92
Hypoacusis  1  2/29 (6.90%)  3 0/29 (0.00%)  0 3/59 (5.08%)  3 3/56 (5.36%)  4 8/173 (4.62%)  10
Middle ear effusion  1  2/29 (6.90%)  2 0/29 (0.00%)  0 1/59 (1.69%)  1 2/56 (3.57%)  2 5/173 (2.89%)  5
Motion sickness  1  1/29 (3.45%)  1 1/29 (3.45%)  1 0/59 (0.00%)  0 3/56 (5.36%)  3 5/173 (2.89%)  5
Tinnitus  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 3/56 (5.36%)  6 3/173 (1.73%)  6
Vertigo  1  1/29 (3.45%)  4 2/29 (6.90%)  2 3/59 (5.08%)  7 3/56 (5.36%)  4 9/173 (5.20%)  17
Eye disorders           
Astigmatism  1  0/29 (0.00%)  0 3/29 (10.34%)  3 0/59 (0.00%)  0 1/56 (1.79%)  1 4/173 (2.31%)  4
Conjunctivitis  1  2/29 (6.90%)  2 2/29 (6.90%)  2 6/59 (10.17%)  9 8/56 (14.29%)  9 18/173 (10.40%)  22
Corneal opacity  1  3/29 (10.34%)  3 5/29 (17.24%)  5 5/59 (8.47%)  5 12/56 (21.43%)  13 25/173 (14.45%)  26
Glaucoma  1  0/29 (0.00%)  0 2/29 (6.90%)  2 0/59 (0.00%)  0 0/56 (0.00%)  0 2/173 (1.16%)  2
Myopia  1  0/29 (0.00%)  0 2/29 (6.90%)  2 1/59 (1.69%)  1 1/56 (1.79%)  1 4/173 (2.31%)  4
Ocular hyperaemia  1  0/29 (0.00%)  0 2/29 (6.90%)  2 3/59 (5.08%)  4 2/56 (3.57%)  3 7/173 (4.05%)  9
Visual impairment  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 3/56 (5.36%)  5 3/173 (1.73%)  5
Gastrointestinal disorders           
Abdominal discomfort  1  3/29 (10.34%)  6 1/29 (3.45%)  1 5/59 (8.47%)  8 7/56 (12.50%)  18 16/173 (9.25%)  33
Abdominal distension  1  3/29 (10.34%)  19 0/29 (0.00%)  0 0/59 (0.00%)  0 2/56 (3.57%)  5 5/173 (2.89%)  24
Abdominal pain  1  12/29 (41.38%)  19 6/29 (20.69%)  8 22/59 (37.29%)  59 24/56 (42.86%)  60 64/173 (36.99%)  146
Abdominal pain lower  1  0/29 (0.00%)  0 1/29 (3.45%)  1 3/59 (5.08%)  3 0/56 (0.00%)  0 4/173 (2.31%)  4
Abdominal pain upper  1  8/29 (27.59%)  15 9/29 (31.03%)  11 9/59 (15.25%)  16 18/56 (32.14%)  72 44/173 (25.43%)  114
Anal pruritus  1  2/29 (6.90%)  2 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 3/173 (1.73%)  3
Breath odour  1  0/29 (0.00%)  0 3/29 (10.34%)  3 0/59 (0.00%)  0 0/56 (0.00%)  0 3/173 (1.73%)  3
Constipation  1  4/29 (13.79%)  5 4/29 (13.79%)  4 7/59 (11.86%)  7 8/56 (14.29%)  9 23/173 (13.29%)  25
Dental caries  1  0/29 (0.00%)  0 3/29 (10.34%)  3 4/59 (6.78%)  4 3/56 (5.36%)  4 10/173 (5.78%)  11
Diarrhoea  1  11/29 (37.93%)  26 11/29 (37.93%)  27 25/59 (42.37%)  71 23/56 (41.07%)  43 70/173 (40.46%)  167
Dyspepsia  1  3/29 (10.34%)  26 5/29 (17.24%)  5 3/59 (5.08%)  5 2/56 (3.57%)  2 13/173 (7.51%)  38
Enterocolitis  1  0/29 (0.00%)  0 0/29 (0.00%)  0 3/59 (5.08%)  3 1/56 (1.79%)  1 4/173 (2.31%)  4
Flatulence  1  2/29 (6.90%)  6 1/29 (3.45%)  1 2/59 (3.39%)  2 1/56 (1.79%)  1 6/173 (3.47%)  10
Gastrooesophageal reflux disease  1  1/29 (3.45%)  1 1/29 (3.45%)  1 2/59 (3.39%)  3 3/56 (5.36%)  4 7/173 (4.05%)  9
Haemorrhoids  1  2/29 (6.90%)  2 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 3/173 (1.73%)  3
Mouth ulceration  1  2/29 (6.90%)  3 0/29 (0.00%)  0 2/59 (3.39%)  3 1/56 (1.79%)  1 5/173 (2.89%)  7
Nausea  1  15/29 (51.72%)  34 10/29 (34.48%)  18 26/59 (44.07%)  65 28/56 (50.00%)  91 79/173 (45.66%)  208
Proctalgia  1  2/29 (6.90%)  2 0/29 (0.00%)  0 0/59 (0.00%)  0 0/56 (0.00%)  0 2/173 (1.16%)  2
Stomatitis  1  0/29 (0.00%)  0 1/29 (3.45%)  1 3/59 (5.08%)  3 1/56 (1.79%)  1 5/173 (2.89%)  5
Toothache  1  3/29 (10.34%)  4 3/29 (10.34%)  5 8/59 (13.56%)  14 4/56 (7.14%)  4 18/173 (10.40%)  27
Vomiting  1  20/29 (68.97%)  105 17/29 (58.62%)  62 39/59 (66.10%)  134 38/56 (67.86%)  160 114/173 (65.90%)  461
General disorders           
Asthenia  1  1/29 (3.45%)  1 2/29 (6.90%)  2 1/59 (1.69%)  2 4/56 (7.14%)  5 8/173 (4.62%)  10
Catheter site pain  1  2/29 (6.90%)  6 0/29 (0.00%)  0 6/59 (10.17%)  6 5/56 (8.93%)  12 13/173 (7.51%)  24
Chest discomfort  1  3/29 (10.34%)  4 2/29 (6.90%)  3 2/59 (3.39%)  2 3/56 (5.36%)  3 10/173 (5.78%)  12
Chest pain  1  1/29 (3.45%)  1 2/29 (6.90%)  2 3/59 (5.08%)  5 4/56 (7.14%)  4 10/173 (5.78%)  12
Chills  1  4/29 (13.79%)  4 1/29 (3.45%)  1 8/59 (13.56%)  10 9/56 (16.07%)  14 22/173 (12.72%)  29
Device dislocation  1  2/29 (6.90%)  2 0/29 (0.00%)  0 3/59 (5.08%)  4 1/56 (1.79%)  1 6/173 (3.47%)  7
Device occlusion  1  1/29 (3.45%)  1 1/29 (3.45%)  3 2/59 (3.39%)  2 4/56 (7.14%)  6 8/173 (4.62%)  12
Effusion  1  0/29 (0.00%)  0 2/29 (6.90%)  2 1/59 (1.69%)  1 1/56 (1.79%)  2 4/173 (2.31%)  5
Extravasation  1  0/29 (0.00%)  0 3/29 (10.34%)  3 3/59 (5.08%)  6 5/56 (8.93%)  5 11/173 (6.36%)  14
Fatigue  1  10/29 (34.48%)  17 13/29 (44.83%)  45 16/59 (27.12%)  32 19/56 (33.93%)  50 58/173 (33.53%)  144
Feeling hot  1  0/29 (0.00%)  0 1/29 (3.45%)  1 4/59 (6.78%)  4 2/56 (3.57%)  3 7/173 (4.05%)  8
Gait disturbance  1  0/29 (0.00%)  0 1/29 (3.45%)  1 3/59 (5.08%)  4 5/56 (8.93%)  5 9/173 (5.20%)  10
Hyperthermia  1  0/29 (0.00%)  0 2/29 (6.90%)  2 0/59 (0.00%)  0 1/56 (1.79%)  1 3/173 (1.73%)  3
Influenza like illness  1  3/29 (10.34%)  3 1/29 (3.45%)  1 1/59 (1.69%)  1 3/56 (5.36%)  4 8/173 (4.62%)  9
Infusion site extravasation  1  3/29 (10.34%)  4 1/29 (3.45%)  2 9/59 (15.25%)  12 4/56 (7.14%)  4 17/173 (9.83%)  22
Infusion site pain  1  2/29 (6.90%)  2 1/29 (3.45%)  1 6/59 (10.17%)  8 4/56 (7.14%)  6 13/173 (7.51%)  17
Infusion site rash  1  2/29 (6.90%)  2 0/29 (0.00%)  0 2/59 (3.39%)  2 1/56 (1.79%)  1 5/173 (2.89%)  5
Infusion site swelling  1  1/29 (3.45%)  1 0/29 (0.00%)  0 3/59 (5.08%)  3 2/56 (3.57%)  2 6/173 (3.47%)  6
Irritability  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 3/56 (5.36%)  5 3/173 (1.73%)  5
Local swelling  1  3/29 (10.34%)  7 0/29 (0.00%)  0 5/59 (8.47%)  5 4/56 (7.14%)  9 12/173 (6.94%)  21
Malaise  1  2/29 (6.90%)  2 3/29 (10.34%)  5 6/59 (10.17%)  7 3/56 (5.36%)  5 14/173 (8.09%)  19
Medical device complication  1  2/29 (6.90%)  2 1/29 (3.45%)  3 5/59 (8.47%)  6 5/56 (8.93%)  8 13/173 (7.51%)  19
Non-cardiac chest pain  1  1/29 (3.45%)  1 1/29 (3.45%)  1 4/59 (6.78%)  4 2/56 (3.57%)  2 8/173 (4.62%)  8
Oedema  1  0/29 (0.00%)  0 2/29 (6.90%)  2 0/59 (0.00%)  0 0/56 (0.00%)  0 2/173 (1.16%)  2
Oedema peripheral  1  1/29 (3.45%)  4 0/29 (0.00%)  0 4/59 (6.78%)  4 3/56 (5.36%)  4 8/173 (4.62%)  12
Pain  1  5/29 (17.24%)  6 1/29 (3.45%)  3 6/59 (10.17%)  8 5/56 (8.93%)  7 17/173 (9.83%)  24
Puncture site pain  1  1/29 (3.45%)  1 0/29 (0.00%)  0 4/59 (6.78%)  4 1/56 (1.79%)  1 6/173 (3.47%)  6
Pyrexia  1  22/29 (75.86%)  91 19/29 (65.52%)  62 38/59 (64.41%)  113 39/56 (69.64%)  231 118/173 (68.21%)  497
Immune system disorders           
Hypersensitivity  1  1/29 (3.45%)  1 0/29 (0.00%)  0 5/59 (8.47%)  8 3/56 (5.36%)  3 9/173 (5.20%)  12
Seasonal allergy  1  2/29 (6.90%)  2 2/29 (6.90%)  4 4/59 (6.78%)  6 2/56 (3.57%)  3 10/173 (5.78%)  15
Infections and infestations           
Bronchitis  1  5/29 (17.24%)  7 3/29 (10.34%)  4 7/59 (11.86%)  8 6/56 (10.71%)  8 21/173 (12.14%)  27
Cellulitis  1  2/29 (6.90%)  2 0/29 (0.00%)  0 0/59 (0.00%)  0 0/56 (0.00%)  0 2/173 (1.16%)  2
Ear infection  1  7/29 (24.14%)  9 3/29 (10.34%)  3 5/59 (8.47%)  13 16/56 (28.57%)  42 31/173 (17.92%)  67
Fungal infection  1  2/29 (6.90%)  2 0/29 (0.00%)  0 2/59 (3.39%)  2 3/56 (5.36%)  3 7/173 (4.05%)  7
Furuncle  1  2/29 (6.90%)  4 0/29 (0.00%)  0 0/59 (0.00%)  0 1/56 (1.79%)  3 3/173 (1.73%)  7
Gastroenteritis  1  5/29 (17.24%)  9 9/29 (31.03%)  13 24/59 (40.68%)  36 17/56 (30.36%)  20 55/173 (31.79%)  78
Gastroenteritis viral  1  2/29 (6.90%)  2 1/29 (3.45%)  1 2/59 (3.39%)  2 2/56 (3.57%)  2 7/173 (4.05%)  7
Gingivitis  1  0/29 (0.00%)  0 2/29 (6.90%)  3 3/59 (5.08%)  3 2/56 (3.57%)  2 7/173 (4.05%)  8
Hordeolum  1  1/29 (3.45%)  2 1/29 (3.45%)  1 6/59 (10.17%)  14 0/56 (0.00%)  0 8/173 (4.62%)  17
Influenza  1  3/29 (10.34%)  7 5/29 (17.24%)  6 11/59 (18.64%)  24 5/56 (8.93%)  6 24/173 (13.87%)  43
Laryngitis  1  0/29 (0.00%)  0 0/29 (0.00%)  0 3/59 (5.08%)  4 0/56 (0.00%)  0 3/173 (1.73%)  4
Lice infestation  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  2 5/56 (8.93%)  6 6/173 (3.47%)  8
Lower respiratory tract infection  1  1/29 (3.45%)  2 1/29 (3.45%)  1 2/59 (3.39%)  2 3/56 (5.36%)  3 7/173 (4.05%)  8
Nasopharyngitis  1  13/29 (44.83%)  34 13/29 (44.83%)  28 29/59 (49.15%)  62 28/56 (50.00%)  67 83/173 (47.98%)  191
Oral candidiasis  1  0/29 (0.00%)  0 1/29 (3.45%)  1 4/59 (6.78%)  7 1/56 (1.79%)  1 6/173 (3.47%)  9
Oral herpes  1  1/29 (3.45%)  2 1/29 (3.45%)  1 4/59 (6.78%)  7 0/56 (0.00%)  0 6/173 (3.47%)  10
Otitis externa  1  3/29 (10.34%)  4 1/29 (3.45%)  1 8/59 (13.56%)  15 6/56 (10.71%)  8 18/173 (10.40%)  28
Otitis media  1  8/29 (27.59%)  10 5/29 (17.24%)  5 11/59 (18.64%)  29 10/56 (17.86%)  18 34/173 (19.65%)  62
Otitis media acute  1  1/29 (3.45%)  2 2/29 (6.90%)  2 5/59 (8.47%)  11 4/56 (7.14%)  6 12/173 (6.94%)  21
Pharyngitis  1  9/29 (31.03%)  12 6/29 (20.69%)  7 8/59 (13.56%)  10 11/56 (19.64%)  18 34/173 (19.65%)  47
Rash pustular  1  2/29 (6.90%)  2 0/29 (0.00%)  0 0/59 (0.00%)  0 0/56 (0.00%)  0 2/173 (1.16%)  2
Respiratory tract infection viral  1  1/29 (3.45%)  1 2/29 (6.90%)  2 3/59 (5.08%)  6 3/56 (5.36%)  4 9/173 (5.20%)  13
Rhinitis  1  9/29 (31.03%)  21 6/29 (20.69%)  17 11/59 (18.64%)  30 9/56 (16.07%)  19 35/173 (20.23%)  87
Sinusitis  1  5/29 (17.24%)  7 1/29 (3.45%)  1 4/59 (6.78%)  4 4/56 (7.14%)  6 14/173 (8.09%)  18
Tinea pedis  1  2/29 (6.90%)  2 1/29 (3.45%)  1 0/59 (0.00%)  0 2/56 (3.57%)  2 5/173 (2.89%)  5
Tonsillitis  1  2/29 (6.90%)  3 2/29 (6.90%)  2 5/59 (8.47%)  8 6/56 (10.71%)  7 15/173 (8.67%)  20
Tooth infection  1  0/29 (0.00%)  0 2/29 (6.90%)  2 1/59 (1.69%)  1 1/56 (1.79%)  2 4/173 (2.31%)  5
Upper respiratory tract infection  1  13/29 (44.83%)  53 8/29 (27.59%)  25 24/59 (40.68%)  82 24/56 (42.86%)  81 69/173 (39.88%)  241
Varicella  1  1/29 (3.45%)  1 0/29 (0.00%)  0 3/59 (5.08%)  3 2/56 (3.57%)  2 6/173 (3.47%)  6
Viral infection  1  1/29 (3.45%)  3 3/29 (10.34%)  5 9/59 (15.25%)  12 5/56 (8.93%)  6 18/173 (10.40%)  26
Viral pharyngitis  1  2/29 (6.90%)  2 0/29 (0.00%)  0 0/59 (0.00%)  0 0/56 (0.00%)  0 2/173 (1.16%)  2
Viral upper respiratory tract infection  1  6/29 (20.69%)  12 0/29 (0.00%)  0 5/59 (8.47%)  9 5/56 (8.93%)  10 16/173 (9.25%)  31
Injury, poisoning and procedural complications           
Arthropod bite  1  0/29 (0.00%)  0 1/29 (3.45%)  1 2/59 (3.39%)  2 6/56 (10.71%)  7 9/173 (5.20%)  10
Contusion  1  3/29 (10.34%)  3 0/29 (0.00%)  0 2/59 (3.39%)  3 2/56 (3.57%)  3 7/173 (4.05%)  9
Excoriation  1  0/29 (0.00%)  0 0/29 (0.00%)  0 4/59 (6.78%)  5 2/56 (3.57%)  2 6/173 (3.47%)  7
Fall  1  4/29 (13.79%)  5 3/29 (10.34%)  4 12/59 (20.34%)  20 5/56 (8.93%)  7 24/173 (13.87%)  36
Head injury  1  1/29 (3.45%)  1 0/29 (0.00%)  0 4/59 (6.78%)  8 2/56 (3.57%)  2 7/173 (4.05%)  11
Infusion related reaction  1  3/29 (10.34%)  5 0/29 (0.00%)  0 2/59 (3.39%)  4 2/56 (3.57%)  3 7/173 (4.05%)  12
Joint dislocation  1  0/29 (0.00%)  0 0/29 (0.00%)  0 4/59 (6.78%)  5 0/56 (0.00%)  0 4/173 (2.31%)  5
Joint injury  1  0/29 (0.00%)  0 0/29 (0.00%)  0 4/59 (6.78%)  4 2/56 (3.57%)  2 6/173 (3.47%)  6
Ligament sprain  1  2/29 (6.90%)  2 1/29 (3.45%)  1 1/59 (1.69%)  1 1/56 (1.79%)  1 5/173 (2.89%)  5
Limb injury  1  2/29 (6.90%)  2 0/29 (0.00%)  0 3/59 (5.08%)  3 1/56 (1.79%)  1 6/173 (3.47%)  6
Procedural pain  1  3/29 (10.34%)  9 2/29 (6.90%)  2 6/59 (10.17%)  7 7/56 (12.50%)  9 18/173 (10.40%)  27
Tooth fracture  1  2/29 (6.90%)  2 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 3/173 (1.73%)  3
Investigations           
Blood cholesterol increased  1  2/29 (6.90%)  2 0/29 (0.00%)  0 0/59 (0.00%)  0 2/56 (3.57%)  2 4/173 (2.31%)  4
Blood pressure diastolic increased  1  0/29 (0.00%)  0 2/29 (6.90%)  4 3/59 (5.08%)  9 3/56 (5.36%)  4 8/173 (4.62%)  17
Blood pressure increased  1  2/29 (6.90%)  6 0/29 (0.00%)  0 3/59 (5.08%)  3 1/56 (1.79%)  1 6/173 (3.47%)  10
Blood pressure systolic increased  1  0/29 (0.00%)  0 2/29 (6.90%)  7 3/59 (5.08%)  28 1/56 (1.79%)  2 6/173 (3.47%)  37
Blood urine present  1  2/29 (6.90%)  5 0/29 (0.00%)  0 1/59 (1.69%)  1 0/56 (0.00%)  0 3/173 (1.73%)  6
Heart rate decreased  1  2/29 (6.90%)  2 0/29 (0.00%)  0 0/59 (0.00%)  0 0/56 (0.00%)  0 2/173 (1.16%)  2
Heart rate increased  1  2/29 (6.90%)  3 1/29 (3.45%)  1 4/59 (6.78%)  4 7/56 (12.50%)  13 14/173 (8.09%)  21
Oxygen saturation decreased  1  6/29 (20.69%)  17 3/29 (10.34%)  15 9/59 (15.25%)  16 10/56 (17.86%)  26 28/173 (16.18%)  74
Respiratory rate increased  1  4/29 (13.79%)  5 1/29 (3.45%)  1 2/59 (3.39%)  2 3/56 (5.36%)  3 10/173 (5.78%)  11
Vital capacity decreased  1  1/29 (3.45%)  1 0/29 (0.00%)  0 3/59 (5.08%)  3 0/56 (0.00%)  0 4/173 (2.31%)  4
Metabolism and nutrition disorders           
Decreased appetite  1  1/29 (3.45%)  1 2/29 (6.90%)  3 1/59 (1.69%)  1 5/56 (8.93%)  5 9/173 (5.20%)  10
Musculoskeletal and connective tissue disorders           
Arthralgia  1  20/29 (68.97%)  90 16/29 (55.17%)  57 40/59 (67.80%)  93 29/56 (51.79%)  94 105/173 (60.69%)  334
Back pain  1  10/29 (34.48%)  17 4/29 (13.79%)  6 19/59 (32.20%)  45 18/56 (32.14%)  46 51/173 (29.48%)  114
Joint swelling  1  2/29 (6.90%)  2 0/29 (0.00%)  0 2/59 (3.39%)  2 1/56 (1.79%)  1 5/173 (2.89%)  5
Knee deformity  1  2/29 (6.90%)  2 5/29 (17.24%)  6 1/59 (1.69%)  1 6/56 (10.71%)  6 14/173 (8.09%)  15
Muscle spasms  1  2/29 (6.90%)  2 3/29 (10.34%)  4 1/59 (1.69%)  1 3/56 (5.36%)  4 9/173 (5.20%)  11
Musculoskeletal chest pain  1  1/29 (3.45%)  3 1/29 (3.45%)  2 5/59 (8.47%)  5 2/56 (3.57%)  2 9/173 (5.20%)  12
Musculoskeletal pain  1  7/29 (24.14%)  14 4/29 (13.79%)  9 10/59 (16.95%)  14 9/56 (16.07%)  20 30/173 (17.34%)  57
Musculoskeletal stiffness  1  2/29 (6.90%)  2 1/29 (3.45%)  2 3/59 (5.08%)  4 1/56 (1.79%)  1 7/173 (4.05%)  9
Myalgia  1  7/29 (24.14%)  11 1/29 (3.45%)  1 3/59 (5.08%)  3 5/56 (8.93%)  9 16/173 (9.25%)  24
Neck pain  1  9/29 (31.03%)  9 3/29 (10.34%)  3 9/59 (15.25%)  14 10/56 (17.86%)  24 31/173 (17.92%)  50
Osteopenia  1  2/29 (6.90%)  2 1/29 (3.45%)  1 4/59 (6.78%)  4 0/56 (0.00%)  0 7/173 (4.05%)  7
Pain in extremity  1  16/29 (55.17%)  54 12/29 (41.38%)  25 27/59 (45.76%)  80 31/56 (55.36%)  102 86/173 (49.71%)  261
Spinal pain  1  3/29 (10.34%)  3 0/29 (0.00%)  0 0/59 (0.00%)  0 5/56 (8.93%)  6 8/173 (4.62%)  9
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Skin papilloma  1  0/29 (0.00%)  0 1/29 (3.45%)  1 3/59 (5.08%)  3 0/56 (0.00%)  0 4/173 (2.31%)  4
Nervous system disorders           
Cervical cord compression  1  2/29 (6.90%)  2 0/29 (0.00%)  0 0/59 (0.00%)  0 0/56 (0.00%)  0 2/173 (1.16%)  2
Dizziness  1  5/29 (17.24%)  6 6/29 (20.69%)  6 8/59 (13.56%)  20 12/56 (21.43%)  30 31/173 (17.92%)  62
Headache  1  23/29 (79.31%)  102 16/29 (55.17%)  67 39/59 (66.10%)  232 36/56 (64.29%)  271 114/173 (65.90%)  672
Hyperreflexia  1  2/29 (6.90%)  3 3/29 (10.34%)  4 1/59 (1.69%)  2 0/56 (0.00%)  0 6/173 (3.47%)  9
Hypoaesthesia  1  1/29 (3.45%)  1 1/29 (3.45%)  1 4/59 (6.78%)  5 1/56 (1.79%)  1 7/173 (4.05%)  8
Lethargy  1  1/29 (3.45%)  1 1/29 (3.45%)  1 3/59 (5.08%)  3 3/56 (5.36%)  4 8/173 (4.62%)  9
Paraesthesia  1  1/29 (3.45%)  1 1/29 (3.45%)  1 2/59 (3.39%)  2 7/56 (12.50%)  18 11/173 (6.36%)  22
Somnolence  1  2/29 (6.90%)  28 3/29 (10.34%)  3 1/59 (1.69%)  1 4/56 (7.14%)  4 10/173 (5.78%)  36
Syncope  1  0/29 (0.00%)  0 2/29 (6.90%)  9 0/59 (0.00%)  0 1/56 (1.79%)  1 3/173 (1.73%)  10
Psychiatric disorders           
Agitation  1  1/29 (3.45%)  1 0/29 (0.00%)  0 2/59 (3.39%)  2 4/56 (7.14%)  6 7/173 (4.05%)  9
Anxiety  1  3/29 (10.34%)  4 3/29 (10.34%)  4 5/59 (8.47%)  7 1/56 (1.79%)  1 12/173 (6.94%)  16
Insomnia  1  2/29 (6.90%)  2 1/29 (3.45%)  1 2/59 (3.39%)  3 0/56 (0.00%)  0 5/173 (2.89%)  6
Renal and urinary disorders           
Dysuria  1  2/29 (6.90%)  2 0/29 (0.00%)  0 3/59 (5.08%)  3 2/56 (3.57%)  2 7/173 (4.05%)  7
Haematuria  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  2 4/56 (7.14%)  4 5/173 (2.89%)  6
Pollakiuria  1  0/29 (0.00%)  0 0/29 (0.00%)  0 4/59 (6.78%)  4 3/56 (5.36%)  3 7/173 (4.05%)  7
Proteinuria  1  2/29 (6.90%)  2 0/29 (0.00%)  0 3/59 (5.08%)  4 3/56 (5.36%)  4 8/173 (4.62%)  10
Reproductive system and breast disorders           
Dysmenorrhoea  1  3/29 (10.34%)  11 1/29 (3.45%)  4 5/59 (8.47%)  24 3/56 (5.36%)  9 12/173 (6.94%)  48
Respiratory, thoracic and mediastinal disorders           
Allergic cough  1  1/29 (3.45%)  2 0/29 (0.00%)  0 3/59 (5.08%)  3 1/56 (1.79%)  1 5/173 (2.89%)  6
Asthma  1  2/29 (6.90%)  2 2/29 (6.90%)  3 5/59 (8.47%)  12 3/56 (5.36%)  11 12/173 (6.94%)  28
Bronchospasm  1  0/29 (0.00%)  0 1/29 (3.45%)  1 5/59 (8.47%)  6 2/56 (3.57%)  2 8/173 (4.62%)  9
Cough  1  21/29 (72.41%)  62 14/29 (48.28%)  49 37/59 (62.71%)  85 28/56 (50.00%)  70 100/173 (57.80%)  266
Dyspnoea  1  6/29 (20.69%)  8 5/29 (17.24%)  7 12/59 (20.34%)  33 11/56 (19.64%)  23 34/173 (19.65%)  71
Epistaxis  1  3/29 (10.34%)  9 4/29 (13.79%)  8 5/59 (8.47%)  6 8/56 (14.29%)  19 20/173 (11.56%)  42
Nasal congestion  1  10/29 (34.48%)  21 4/29 (13.79%)  6 15/59 (25.42%)  24 16/56 (28.57%)  38 45/173 (26.01%)  89
Nasal obstruction  1  3/29 (10.34%)  10 3/29 (10.34%)  3 6/59 (10.17%)  7 3/56 (5.36%)  3 15/173 (8.67%)  23
Neonatal hypoxia  1  0/29 (0.00%)  0 0/29 (0.00%)  0 2/59 (3.39%)  2 3/56 (5.36%)  4 5/173 (2.89%)  6
Obstructive airways disorder  1  0/29 (0.00%)  0 1/29 (3.45%)  1 1/59 (1.69%)  1 3/56 (5.36%)  4 5/173 (2.89%)  6
Oropharyngeal pain  1  13/29 (44.83%)  24 11/29 (37.93%)  16 23/59 (38.98%)  48 27/56 (48.21%)  63 74/173 (42.77%)  151
Pharyngeal disorder  1  2/29 (6.90%)  2 0/29 (0.00%)  0 0/59 (0.00%)  0 0/56 (0.00%)  0 2/173 (1.16%)  2
Pharyngeal erythema  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 3/56 (5.36%)  5 3/173 (1.73%)  5
Productive cough  1  1/29 (3.45%)  1 3/29 (10.34%)  3 2/59 (3.39%)  2 0/56 (0.00%)  0 6/173 (3.47%)  6
Respiratory tract congestion  1  0/29 (0.00%)  0 0/29 (0.00%)  0 3/59 (5.08%)  5 1/56 (1.79%)  1 4/173 (2.31%)  6
Restrictive pulmonary disease  1  2/29 (6.90%)  2 0/29 (0.00%)  0 1/59 (1.69%)  1 1/56 (1.79%)  2 4/173 (2.31%)  5
Rhinitis allergic  1  3/29 (10.34%)  3 5/29 (17.24%)  7 9/59 (15.25%)  14 2/56 (3.57%)  2 19/173 (10.98%)  26
Rhinorrhoea  1  5/29 (17.24%)  6 5/29 (17.24%)  10 7/59 (11.86%)  16 14/56 (25.00%)  24 31/173 (17.92%)  56
Sinus congestion  1  2/29 (6.90%)  2 1/29 (3.45%)  1 0/59 (0.00%)  0 3/56 (5.36%)  4 6/173 (3.47%)  7
Sleep apnoea syndrome  1  1/29 (3.45%)  1 2/29 (6.90%)  2 4/59 (6.78%)  4 2/56 (3.57%)  2 9/173 (5.20%)  9
Sneezing  1  2/29 (6.90%)  2 1/29 (3.45%)  1 1/59 (1.69%)  1 2/56 (3.57%)  2 6/173 (3.47%)  6
Tachypnoea  1  3/29 (10.34%)  3 1/29 (3.45%)  1 3/59 (5.08%)  6 2/56 (3.57%)  4 9/173 (5.20%)  14
Throat irritation  1  3/29 (10.34%)  3 1/29 (3.45%)  1 0/59 (0.00%)  0 4/56 (7.14%)  5 8/173 (4.62%)  9
Tonsillar hypertrophy  1  2/29 (6.90%)  3 2/29 (6.90%)  2 2/59 (3.39%)  3 1/56 (1.79%)  1 7/173 (4.05%)  9
Wheezing  1  5/29 (17.24%)  10 5/29 (17.24%)  6 6/59 (10.17%)  8 4/56 (7.14%)  6 20/173 (11.56%)  30
Skin and subcutaneous tissue disorders           
Acne  1  2/29 (6.90%)  2 3/29 (10.34%)  3 2/59 (3.39%)  2 3/56 (5.36%)  4 10/173 (5.78%)  11
Blister  1  0/29 (0.00%)  0 0/29 (0.00%)  0 3/59 (5.08%)  6 2/56 (3.57%)  4 5/173 (2.89%)  10
Dermatitis  1  1/29 (3.45%)  1 0/29 (0.00%)  0 1/59 (1.69%)  1 3/56 (5.36%)  4 5/173 (2.89%)  6
Dermatitis allergic  1  2/29 (6.90%)  2 0/29 (0.00%)  0 5/59 (8.47%)  5 0/56 (0.00%)  0 7/173 (4.05%)  7
Dry skin  1  3/29 (10.34%)  3 0/29 (0.00%)  0 1/59 (1.69%)  1 2/56 (3.57%)  3 6/173 (3.47%)  7
Eczema  1  2/29 (6.90%)  2 4/29 (13.79%)  7 8/59 (13.56%)  10 1/56 (1.79%)  2 15/173 (8.67%)  21
Erythema  1  6/29 (20.69%)  12 3/29 (10.34%)  4 7/59 (11.86%)  7 10/56 (17.86%)  29 26/173 (15.03%)  52
Hyperhidrosis  1  1/29 (3.45%)  1 4/29 (13.79%)  6 1/59 (1.69%)  1 3/56 (5.36%)  3 9/173 (5.20%)  11
Petechiae  1  0/29 (0.00%)  0 0/29 (0.00%)  0 4/59 (6.78%)  4 0/56 (0.00%)  0 4/173 (2.31%)  4
Pruritus  1  7/29 (24.14%)  18 3/29 (10.34%)  6 8/59 (13.56%)  28 19/56 (33.93%)  32 37/173 (21.39%)  84
Rash  1  8/29 (27.59%)  13 8/29 (27.59%)  30 15/59 (25.42%)  61 19/56 (33.93%)  103 50/173 (28.90%)  207
Rash erythematous  1  2/29 (6.90%)  3 0/29 (0.00%)  0 1/59 (1.69%)  3 1/56 (1.79%)  1 4/173 (2.31%)  7
Rash macular  1  1/29 (3.45%)  5 1/29 (3.45%)  1 1/59 (1.69%)  1 3/56 (5.36%)  3 6/173 (3.47%)  10
Rash maculo-papular  1  0/29 (0.00%)  0 0/29 (0.00%)  0 3/59 (5.08%)  59 2/56 (3.57%)  28 5/173 (2.89%)  87
Rash pruritic  1  0/29 (0.00%)  0 0/29 (0.00%)  0 3/59 (5.08%)  3 0/56 (0.00%)  0 3/173 (1.73%)  3
Skin disorder  1  0/29 (0.00%)  0 0/29 (0.00%)  0 0/59 (0.00%)  0 3/56 (5.36%)  7 3/173 (1.73%)  7
Skin lesion  1  2/29 (6.90%)  2 1/29 (3.45%)  1 3/59 (5.08%)  3 3/56 (5.36%)  3 9/173 (5.20%)  9
Urticaria  1  6/29 (20.69%)  38 1/29 (3.45%)  37 11/59 (18.64%)  53 12/56 (21.43%)  33 30/173 (17.34%)  161
Surgical and medical procedures           
Central venous catheterisation  1  1/29 (3.45%)  1 1/29 (3.45%)  1 3/59 (5.08%)  3 1/56 (1.79%)  1 6/173 (3.47%)  6
Tooth extraction  1  1/29 (3.45%)  1 2/29 (6.90%)  2 4/59 (6.78%)  6 0/56 (0.00%)  0 7/173 (4.05%)  9
Vascular disorders           
Flushing  1  1/29 (3.45%)  3 2/29 (6.90%)  2 2/59 (3.39%)  2 5/56 (8.93%)  8 10/173 (5.78%)  15
Hot flush  1  0/29 (0.00%)  0 2/29 (6.90%)  6 3/59 (5.08%)  5 2/56 (3.57%)  2 7/173 (4.05%)  13
Hypertension  1  1/29 (3.45%)  1 4/29 (13.79%)  13 6/59 (10.17%)  28 6/56 (10.71%)  16 17/173 (9.83%)  58
Hypotension  1  2/29 (6.90%)  2 1/29 (3.45%)  1 3/59 (5.08%)  6 6/56 (10.71%)  7 12/173 (6.94%)  16
Pallor  1  2/29 (6.90%)  3 2/29 (6.90%)  2 2/59 (3.39%)  4 7/56 (12.50%)  21 13/173 (7.51%)  30
Poor venous access  1  6/29 (20.69%)  21 5/29 (17.24%)  10 6/59 (10.17%)  7 8/56 (14.29%)  16 25/173 (14.45%)  54
1
Term from vocabulary, MedDRA 16.1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Peter Slasor/Sr Director, Biostatistics, Global Clinical Sciences
Organization: BioMarin Pharmaceutical Inc.
Phone: 415-506-6765
Responsible Party: BioMarin Pharmaceutical
ClinicalTrials.gov Identifier: NCT01415427     History of Changes
Other Study ID Numbers: MOR-005
First Submitted: August 8, 2011
First Posted: August 12, 2011
Results First Submitted: April 13, 2017
Results First Posted: May 19, 2017
Last Update Posted: May 19, 2017