Extension Study for Patients Who Have Participated in a BMN 701 Study
Study Details
Study Description
Brief Summary
This is a Phase 2 open-label, multiple dose study of BMN 701 administered by IV infusion every 2 weeks (qow) to patients with late-onset Pompe disease.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: BMN 701 20mg/kg BMN 701 20mg/kg IV every other week |
Biological: BMN 701
GILT-tagged recombinant human GAA
|
Experimental: BMN 701 10mg/kg BMN 701 10mg/kg IV every other week |
Biological: BMN 701
GILT-tagged recombinant human GAA
|
Experimental: BMN 701 5mg/kg BMN 701 5mg/kg IV every other week |
Biological: BMN 701
GILT-tagged recombinant human GAA
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With a Positive Anti-BMN 701 Antibody [Baseline, Week 144]
Status of Anti-BMN 701 antibody is corresponding to the test results of blood samples.
- Number of Participants With a Positive Anti-BMN 701 Antibody Response [Baseline, Week 144]
Status of Anti-IGF-I antibody is corresponding to the test results of blood samples
- Number of Participants With a Positive Anti-BMN 701 Antibody Response [Baseline, Week 144]
Status of Anti-IGF-II antibody is corresponding to the test results of blood samples
Secondary Outcome Measures
- Percent Predicted Maximal Inspiratory Pressure (MIP) [Baseline, Week 144]
Pulmonary Function Test: Percent Predicted Maximal Inspiratory Pressure
- Percent Predicted Maximum Expiratory Pressure (MEP) [Baseline, Week 144]
Pulmonary Function Test: Percent Predicted Maximum Expiratory Pressure
- 6 Minutes Walk Test (Meters) [Baseline, Week 144]
Distance walked within 6 minutes
- Maximum Voluntary Ventilation (MVV) [Baseline, Week 144]
Pulmonary function test: Maximum Voluntary Ventilation (MVV)
- Percent Predicted Upright Forced Vital Capacity (FVC) [Baseline, Week 144]
Pulmonary function test: Percent Predicted Upright Forced Vital Capacity
- Change From Baseline in Urine Tetrasaccharide Concentration at Week 144 [Baseline, Week 144]
Change from Baseline in Urine Tetrasaccharide Concentration at Week 144
- Plasma IGF-I Concentration [Baseline, Week 144]
Plasma IGF-I concentration from lab
- Plasma IGF-II Concentration [Baseline, Week 144]
Plasma IGF-II concentration from lab
- Insulin-like Growth Factor Binding Protein 3 (IGFBP3) [Baseline, Week 144]
insulin-like growth factor binding protein 3 from lab
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have completed a prior BMN 701 clinical development study;
-
Have provided written informed consent after the nature of the study has been explained prior to performance of any study-related procedures. Minors may participate as long as they provide written assent after the nature of the study has been explained to them and after their parent, or legal guardian has provided written informed consent, prior to the performance of any study-related procedures;
-
Have been diagnosed with late-onset Pompe Disease, based on the entry criteria of a prior BMN 701 study;
-
If sexually active, be willing to use 2 known effective methods of contraception from Screening until 4 months after the last dose of study-drug;
-
If female, and not considered to be of childbearing potential, be at least 2 years post-menopausal, or have had tubal ligation at least 1 year prior to screening, or have had a total hysterectomy;
-
If female, and of childbearing potential, have a negative pregnancy test during the Screening Period and at the Baseline visit, and be willing to have additional pregnancy tests during the study;
-
Have the ability to comply with the protocol requirements, in the opinion of the Investigator.
Exclusion Criteria:
-
Have received any experimental or approved therapy for Pompe disease, other than BMN 701, subsequent to completion of a BMN 701 study and prior to entry into POM-002;
-
Have received, or are anticipated to receive, any investigational medication, other than BMN 701, within 30 days prior to the first dose of study-drug;
-
Are breastfeeding at screening or planning to become pregnant (self or partner) at any time during the study;
-
Have a medical condition or extenuating circumstance that, in the opinion of the Investigator, might compromise the patient's ability to comply with the protocol requirements or compromise the patient's well being or safety.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Univ of California San Diego School of Medicine | San Diego | California | United States | 92103 |
2 | University of Florida College of Medicine | Gainesville | Florida | United States | 32610 |
3 | Tampa General Hospital | Tampa | Florida | United States | 33606 |
4 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
5 | Royal Brisbane and Women's Hospital | Herston | Queensland | Australia | 4029 |
6 | Royal Adelaide Hospital | North Adelaide | South Australia | Australia | 5006 |
7 | Hôpital Pitié-Salpêtrière | Paris | France | 75013 | |
8 | Villa Metabolica, ZKJM MC University Mainz | Mainz | Germany | 55131 | |
9 | Auckland City and Starship Children's Hospital | Auckland | New Zealand | 1142 | |
10 | University Hospitals Birmingham NHS Foundation Trust | Birmingham | United Kingdom | B15 2TH | |
11 | Royal Free Hospital | London | United Kingdom | NW3 2QG | |
12 | Salford Royal NHS Foundation Trust | Salford | United Kingdom | M5 5AP |
Sponsors and Collaborators
- BioMarin Pharmaceutical
Investigators
- Study Director: Medical Monitor, BioMarin Pharmaceutical
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- POM-002
- 2011-001805-28
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | BMN 701 5 mg/kg | BMN 701 10 mg/kg | BMN 701 20 mg/kg |
---|---|---|---|
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 |
Baseline Characteristics
Arm/Group Title | BMN 701 5 mg/kg | BMN 701 10 mg/kg | BMN 701 20 mg/kg | Total |
---|---|---|---|---|
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 Participants | 3 | 3 | 15 | 21 |
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
52.3
(6.66)
|
42.7
(13.05)
|
50.1
(5.28)
|
49.4
(7.03)
|
Age, Customized (Count of Participants) | ||||
18-65 years |
3
100%
|
3
100%
|
15
100%
|
21
100%
|
Sex: Female, Male (Count of Participants) | ||||
Female |
0
0%
|
2
66.7%
|
6
40%
|
8
38.1%
|
Male |
3
100%
|
1
33.3%
|
9
60%
|
13
61.9%
|
Ethnicity (NIH/OMB) (Count of Participants) | ||||
Hispanic or Latino |
0
0%
|
1
33.3%
|
0
0%
|
1
4.8%
|
Not Hispanic or Latino |
3
100%
|
2
66.7%
|
15
100%
|
20
95.2%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Race/Ethnicity, Customized (Count of Participants) | ||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
White |
3
100%
|
3
100%
|
14
93.3%
|
20
95.2%
|
Other |
0
0%
|
0
0%
|
1
6.7%
|
1
4.8%
|
Region of Enrollment (Count of Participants) | ||||
Australia |
1
33.3%
|
1
33.3%
|
4
26.7%
|
6
28.6%
|
France |
0
0%
|
0
0%
|
1
6.7%
|
1
4.8%
|
Germany |
0
0%
|
0
0%
|
1
6.7%
|
1
4.8%
|
United Kingdom |
0
0%
|
0
0%
|
6
40%
|
6
28.6%
|
United States |
2
66.7%
|
2
66.7%
|
3
20%
|
7
33.3%
|
Outcome Measures
Title | Number of Participants With a Positive Anti-BMN 701 Antibody |
---|---|
Description | Status of Anti-BMN 701 antibody is corresponding to the test results of blood samples. |
Time Frame | Baseline, Week 144 |
Outcome Measure Data
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 |
---|---|---|---|
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 |
Measure Participants | 3 | 3 | 15 |
Baseline |
2
66.7%
|
1
33.3%
|
11
73.3%
|
Week 144 |
2
66.7%
|
2
66.7%
|
10
66.7%
|
Title | Number of Participants With a Positive Anti-BMN 701 Antibody Response |
---|---|
Description | Status of Anti-IGF-I antibody is corresponding to the test results of blood samples |
Time Frame | Baseline, Week 144 |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set. |
Arm/Group Title | BMN 701 5 mg/kg | BMN 701 10 mg/kg | BMN 701 20 mg/kg |
---|---|---|---|
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 |
Measure Participants | 3 | 3 | 15 |
Baseline |
0
0%
|
2
66.7%
|
0
0%
|
Week 144 |
0
0%
|
1
33.3%
|
5
33.3%
|
Title | Number of Participants With a Positive Anti-BMN 701 Antibody Response |
---|---|
Description | Status of Anti-IGF-II antibody is corresponding to the test results of blood samples |
Time Frame | Baseline, Week 144 |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set. |
Arm/Group Title | BMN 701 5 mg/kg | BMN 701 10 mg/kg | BMN 701 20 mg/kg |
---|---|---|---|
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 |
Measure Participants | 3 | 3 | 15 |
Baseline |
1
33.3%
|
2
66.7%
|
2
13.3%
|
Week 144 |
0
0%
|
2
66.7%
|
7
46.7%
|
Title | Percent Predicted Maximal Inspiratory Pressure (MIP) |
---|---|
Description | Pulmonary Function Test: Percent Predicted Maximal Inspiratory Pressure |
Time Frame | Baseline, Week 144 |
Outcome Measure Data
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 |
---|---|---|---|
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 |
Measure Participants | 0 | 3 | 15 |
Baseline |
39.53
(21.868)
|
40.2
(25.863)
|
|
Change from Baseline to Week 144 |
21.17
(14.537)
|
18.48
(18.599)
|
Title | Percent Predicted Maximum Expiratory Pressure (MEP) |
---|---|
Description | Pulmonary Function Test: Percent Predicted Maximum Expiratory Pressure |
Time Frame | Baseline, Week 144 |
Outcome Measure Data
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 |
---|---|---|---|
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 |
Measure Participants | 0 | 3 | 15 |
Baseline |
31.07
(6.641)
|
36.7
(15.939)
|
|
Change from Baseline to Week 144 |
-0.28
(5.841)
|
5.11
(16.395)
|
Title | 6 Minutes Walk Test (Meters) |
---|---|
Description | Distance walked within 6 minutes |
Time Frame | Baseline, Week 144 |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set. |
Arm/Group Title | BMN 701 5 mg/kg | BMN 701 10 mg/kg | BMN 701 20 mg/kg |
---|---|---|---|
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 |
Measure Participants | 3 | 3 | 15 |
Baseline |
334
(227.119)
|
360
(51.403)
|
363.8
(157.818)
|
Change from Baseline to Week 144 |
-36
(90.508)
|
-120.75
(67.529)
|
9.5
(77.572)
|
Title | Maximum Voluntary Ventilation (MVV) |
---|---|
Description | Pulmonary function test: Maximum Voluntary Ventilation (MVV) |
Time Frame | Baseline, Week 144 |
Outcome Measure Data
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 |
---|---|---|---|
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 |
Measure Participants | 0 | 3 | 15 |
Baseline |
76
(41.037)
|
68.08
(26.74)
|
|
Change from Baseline to Week 144 |
13.5
(13.435)
|
2.24
(11.635)
|
Title | Percent Predicted Upright Forced Vital Capacity (FVC) |
---|---|
Description | Pulmonary function test: Percent Predicted Upright Forced Vital Capacity |
Time Frame | Baseline, Week 144 |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set. |
Arm/Group Title | BMN 701 5 mg/kg | BMN 701 10 mg/kg | BMN 701 20 mg/kg |
---|---|---|---|
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 |
Measure Participants | 3 | 3 | 15 |
Baseline |
69.33
(19.732)
|
67.33
(26.577)
|
57.13
(18.677)
|
Change from Baseline to Week 144 |
-8.33
(7.095)
|
-0.5
(4.95)
|
-2
(8)
|
Title | Percent Predicted Upright Forced Vital Capacity (FVC) |
---|---|
Description | Pulmonary function test: Percent Predicted Upright Forced Vital capacity |
Time Frame | Baseline, Week 144 |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set. |
Arm/Group Title | BMN 701 5 mg/kg | BMN 701 10 mg/kg | BMN 701 20 mg/kg |
---|---|---|---|
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 |
Measure Participants | 3 | 3 | 15 |
Baseline |
36.67
(17.954)
|
47.67
(32.578)
|
44.25
(21.55)
|
Change from Baseline to Week 144 |
-4.33
(9.452)
|
4.5
(26.163)
|
-3.43
(6.901)
|
Title | Change From Baseline in Urine Tetrasaccharide Concentration at Week 144 |
---|---|
Description | Change from Baseline in Urine Tetrasaccharide Concentration at Week 144 |
Time Frame | Baseline, Week 144 |
Outcome Measure Data
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 |
---|---|---|---|
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 |
Measure Participants | 0 | 2 | 10 |
Mean (Standard Deviation) [mmol/mol] |
-0.2
(3.394)
|
-1.07
(0.975)
|
Title | Plasma IGF-I Concentration |
---|---|
Description | Plasma IGF-I concentration from lab |
Time Frame | Baseline, Week 144 |
Outcome Measure Data
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 |
---|---|---|---|
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 |
Measure Participants | 2 | 2 | 15 |
Baseline |
20.26
(6.465)
|
||
Week 144 |
26.98
(1.379)
|
18.4
(7.078)
|
17.62
(5.878)
|
Title | Plasma IGF-II Concentration |
---|---|
Description | Plasma IGF-II concentration from lab |
Time Frame | Baseline, Week 144 |
Outcome Measure Data
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 |
---|---|---|---|
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 |
Measure Participants | 3 | 3 | 15 |
Baseline |
702
(0)
|
496.83
(113.417)
|
|
Week 144 |
467.67
(117.142)
|
559.5
(140.714)
|
698.82
(228.948)
|
Title | Insulin-like Growth Factor Binding Protein 3 (IGFBP3) |
---|---|
Description | insulin-like growth factor binding protein 3 from lab |
Time Frame | Baseline, Week 144 |
Outcome Measure Data
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 |
---|---|---|---|
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 |
Measure Participants | 3 | 2 | 15 |
Baseline |
150.45
(23.914)
|
||
Week 144 |
157.33
(41.477)
|
209
(39.598)
|
146.64
(33.587)
|
Adverse Events
Time Frame | 284.9 weeks (maximum exposure) +4 weeks follow up | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||
Arm/Group Title | BMN 701 5 mg/kg | BMN 701 10 mg/kg | BMN 701 20 mg/kg | Total | ||||
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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 0/21 (0%) | ||||
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 (66.7%) | 1/3 (33.3%) | 7/15 (46.7%) | 10/21 (47.6%) | ||||
Cardiac disorders | ||||||||
Cardiac failure acute | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Myocardial infarction | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Gastrointestinal disorders | ||||||||
Gastrooesophageal reflux disease | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
General disorders | ||||||||
Fatigue | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Immune system disorders | ||||||||
Anaphylactoid reaction | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/21 (4.8%) | 2 |
Infections and infestations | ||||||||
Pneumonia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Injury, poisoning and procedural complications | ||||||||
Fall | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Tendon rupture | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Metabolism and nutrition disorders | ||||||||
Hypoglycaemia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Nervous system disorders | ||||||||
Cerebrovascular accident | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Presyncope | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Renal and urinary disorders | ||||||||
Prerenal failure | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||||||||
Chronic respiratory failure | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Respiratory failure | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Stridor | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Other (Not Including 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 | 3/3 (100%) | 3/3 (100%) | 15/15 (100%) | 21/21 (100%) | ||||
Blood and lymphatic system disorders | ||||||||
Anaemia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Iron deficiency anaemia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Cardiac disorders | ||||||||
Bradycardia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Cardiac failure | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Diastolic dysfunction | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Left ventricular hypertrophy | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Sinus tachycardia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 3/15 (20%) | 4 | 3/21 (14.3%) | 4 |
Tachycardia | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 5/15 (33.3%) | 49 | 7/21 (33.3%) | 51 |
Ear and labyrinth disorders | ||||||||
Ear discomfort | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Tinnitus | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Vertigo positional | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Endocrine disorders | ||||||||
Androgen deficiency | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Eye disorders | ||||||||
Blindness transient | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Ocular hyperaemia | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Visual impairment | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Gastrointestinal disorders | ||||||||
Abdominal discomfort | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 1/15 (6.7%) | 3 | 3/21 (14.3%) | 5 |
Abdominal distension | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Abdominal pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/15 (13.3%) | 3 | 2/21 (9.5%) | 3 |
Abdominal pain lower | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Abdominal pain upper | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 3/15 (20%) | 5 | 5/21 (23.8%) | 7 |
Abdominal tenderness | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Constipation | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 3/15 (20%) | 4 | 3/21 (14.3%) | 4 |
Dental caries | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Diarrhoea | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 7/15 (46.7%) | 13 | 7/21 (33.3%) | 13 |
Dyspepsia | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Flatulence | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Gastrooesophageal reflux disease | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 3/15 (20%) | 3 | 3/21 (14.3%) | 3 |
Irritable bowel syndrome | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/15 (13.3%) | 3 | 2/21 (9.5%) | 3 |
Nausea | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 6/15 (40%) | 29 | 8/21 (38.1%) | 31 |
Painful defaecation | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Rectal haemorrhage | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Salivary hypersecretion | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/15 (13.3%) | 2 | 2/21 (9.5%) | 2 |
Tooth loss | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Toothache | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 5 | 1/21 (4.8%) | 5 |
Vomiting | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 3/15 (20%) | 4 | 3/21 (14.3%) | 4 |
General disorders | ||||||||
Application site erythema | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/15 (13.3%) | 2 | 2/21 (9.5%) | 2 |
Asthenia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/15 (13.3%) | 2 | 2/21 (9.5%) | 2 |
Catheter site erythema | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Catheter site inflammation | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Catheter site pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/15 (13.3%) | 2 | 2/21 (9.5%) | 2 |
Chest discomfort | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 5/15 (33.3%) | 19 | 6/21 (28.6%) | 20 |
Chest pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Chills | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 3/15 (20%) | 5 | 3/21 (14.3%) | 5 |
Discomfort | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Extravasation | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Fatigue | 2/3 (66.7%) | 18 | 0/3 (0%) | 0 | 8/15 (53.3%) | 16 | 10/21 (47.6%) | 34 |
Feeling abnormal | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/15 (13.3%) | 2 | 2/21 (9.5%) | 2 |
Feeling cold | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 2/15 (13.3%) | 10 | 3/21 (14.3%) | 11 |
Feeling hot | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 3/15 (20%) | 7 | 4/21 (19%) | 8 |
Feeling of body temperature change | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Gait disturbance | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Influenza like illness | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Infusion site extravasation | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/21 (4.8%) | 2 |
Infusion site pain | 2/3 (66.7%) | 2 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 2/21 (9.5%) | 2 |
Infusion site swelling | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Malaise | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 4/15 (26.7%) | 5 | 5/21 (23.8%) | 6 |
Non-cardiac chest pain | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 2/15 (13.3%) | 2 | 3/21 (14.3%) | 3 |
Oedema peripheral | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 3/15 (20%) | 8 | 3/21 (14.3%) | 8 |
Pain | 2/3 (66.7%) | 2 | 0/3 (0%) | 0 | 1/15 (6.7%) | 2 | 3/21 (14.3%) | 4 |
Peripheral swelling | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 3/15 (20%) | 3 | 5/21 (23.8%) | 5 |
Pyrexia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/15 (13.3%) | 2 | 2/21 (9.5%) | 2 |
Temperature intolerance | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Tenderness | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 0/15 (0%) | 0 | 1/21 (4.8%) | 2 |
Vessel puncture site bruise | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Hepatobiliary disorders | ||||||||
Cholelithiasis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Immune system disorders | ||||||||
Seasonal allergy | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 2 | 1/21 (4.8%) | 2 |
Infections and infestations | ||||||||
Blister infected | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Bronchitis | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Ear infection | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Fungal infection | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/15 (13.3%) | 2 | 2/21 (9.5%) | 2 |
Gastroenteritis viral | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Herpes simplex | 1/3 (33.3%) | 3 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/21 (4.8%) | 3 |
Influenza | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 3/15 (20%) | 3 | 4/21 (19%) | 4 |
Lower respiratory tract infection | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 4/15 (26.7%) | 9 | 6/21 (28.6%) | 11 |
Lower respiratory tract infection viral | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/15 (13.3%) | 2 | 2/21 (9.5%) | 2 |
Nasopharyngitis | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 4/15 (26.7%) | 7 | 5/21 (23.8%) | 8 |
Rhinitis | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 2/15 (13.3%) | 2 | 3/21 (14.3%) | 3 |
Sinusitis | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Upper respiratory tract infection | 1/3 (33.3%) | 3 | 2/3 (66.7%) | 6 | 7/15 (46.7%) | 11 | 10/21 (47.6%) | 20 |
Urinary tract infection | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 1/15 (6.7%) | 1 | 2/21 (9.5%) | 3 |
Viral infection | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 1/15 (6.7%) | 2 | 2/21 (9.5%) | 4 |
Viral upper respiratory tract infection | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 2 | 1/21 (4.8%) | 2 |
Injury, poisoning and procedural complications | ||||||||
Contusion | 2/3 (66.7%) | 5 | 1/3 (33.3%) | 1 | 6/15 (40%) | 9 | 9/21 (42.9%) | 15 |
Epicondylitis | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Eye contusion | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Fall | 3/3 (100%) | 22 | 2/3 (66.7%) | 5 | 7/15 (46.7%) | 26 | 12/21 (57.1%) | 53 |
Head injury | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Joint injury | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Laceration | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 2/21 (9.5%) | 2 |
Muscle contusion | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Muscle strain | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 2/21 (9.5%) | 2 |
Post procedural contusion | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Post procedural haemorrhage | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Procedural pain | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 2/15 (13.3%) | 2 | 3/21 (14.3%) | 4 |
Skin abrasion | 2/3 (66.7%) | 5 | 1/3 (33.3%) | 1 | 1/15 (6.7%) | 1 | 4/21 (19%) | 7 |
Skin wound | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Tendon injury | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Thermal burn | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Tooth fracture | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 3 | 1/21 (4.8%) | 3 |
Wound | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Investigations | ||||||||
Ammonia increased | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Bacterial test positive | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 2 | 1/21 (4.8%) | 2 |
Blood calcium decreased | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Blood glucose decreased | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 7/15 (46.7%) | 14 | 7/21 (33.3%) | 14 |
Blood immunoglobulin E increased | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Cardiac murmur | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 2/21 (9.5%) | 2 |
Complement factor increased | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Lipase increased | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Pulmonary physical examination abnormal | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Troponin increased | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Tryptase increased | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Metabolism and nutrition disorders | ||||||||
Dehydration | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 2 | 1/21 (4.8%) | 2 |
Glucose tolerance impaired | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Hyperglycaemia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 2 | 1/21 (4.8%) | 2 |
Hyperkalaemia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Hypoglycaemia | 1/3 (33.3%) | 19 | 1/3 (33.3%) | 30 | 14/15 (93.3%) | 106 | 16/21 (76.2%) | 155 |
Iron deficiency | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Musculoskeletal and connective tissue disorders | ||||||||
Arthralgia | 2/3 (66.7%) | 8 | 1/3 (33.3%) | 1 | 7/15 (46.7%) | 18 | 10/21 (47.6%) | 27 |
Back pain | 3/3 (100%) | 6 | 1/3 (33.3%) | 1 | 7/15 (46.7%) | 10 | 11/21 (52.4%) | 17 |
Bursitis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Flank pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/15 (13.3%) | 2 | 2/21 (9.5%) | 2 |
Groin pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Intervertebral disc protrusion | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Joint swelling | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Muscle spasms | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 3/15 (20%) | 9 | 4/21 (19%) | 10 |
Muscle twitching | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Muscular weakness | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 2/15 (13.3%) | 2 | 3/21 (14.3%) | 3 |
Musculoskeletal chest pain | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 2/21 (9.5%) | 2 |
Musculoskeletal discomfort | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Musculoskeletal pain | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 2/15 (13.3%) | 3 | 3/21 (14.3%) | 4 |
Myalgia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 3/15 (20%) | 4 | 3/21 (14.3%) | 4 |
Neck pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 3/15 (20%) | 4 | 3/21 (14.3%) | 4 |
Osteopenia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Pain in extremity | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 8/15 (53.3%) | 14 | 10/21 (47.6%) | 16 |
Spinal pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Tendonitis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
Skin papilloma | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Nervous system disorders | ||||||||
Balance disorder | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Burning sensation | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 2/15 (13.3%) | 2 | 3/21 (14.3%) | 3 |
Dizziness | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 5 | 8/15 (53.3%) | 11 | 10/21 (47.6%) | 17 |
Headache | 2/3 (66.7%) | 7 | 1/3 (33.3%) | 4 | 9/15 (60%) | 30 | 12/21 (57.1%) | 41 |
Hypoaesthesia | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 3/15 (20%) | 3 | 5/21 (23.8%) | 5 |
Lethargy | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Migraine | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Paraesthesia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 2 | 1/21 (4.8%) | 2 |
Presyncope | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Restless legs syndrome | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Sciatica | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Sinus headache | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/21 (4.8%) | 2 |
Tremor | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/15 (13.3%) | 2 | 2/21 (9.5%) | 2 |
Tunnel vision | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Product Issues | ||||||||
Device occlusion | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Psychiatric disorders | ||||||||
Anxiety | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 2 | 1/21 (4.8%) | 2 |
Confusional state | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Insomnia | 1/3 (33.3%) | 2 | 1/3 (33.3%) | 1 | 2/15 (13.3%) | 2 | 4/21 (19%) | 5 |
Mood swings | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Nervousness | 1/3 (33.3%) | 4 | 1/3 (33.3%) | 1 | 4/15 (26.7%) | 6 | 6/21 (28.6%) | 11 |
Restlessness | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 2/15 (13.3%) | 2 | 3/21 (14.3%) | 3 |
Sleep terror | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Renal and urinary disorders | ||||||||
Haematuria | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 2/15 (13.3%) | 2 | 3/21 (14.3%) | 3 |
Renal impairment | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||||||||
Asthma | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Chronic respiratory failure | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Cough | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 3/15 (20%) | 8 | 3/21 (14.3%) | 8 |
Dyspnoea | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 9/15 (60%) | 26 | 10/21 (47.6%) | 27 |
Epistaxis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 2 | 1/21 (4.8%) | 2 |
Hypoxia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 2 | 1/21 (4.8%) | 2 |
Nasal congestion | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/15 (13.3%) | 2 | 2/21 (9.5%) | 2 |
Oropharyngeal pain | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 2 | 5/15 (33.3%) | 12 | 7/21 (33.3%) | 15 |
Paranasal sinus hypersecretion | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Pleuritic pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/15 (13.3%) | 2 | 2/21 (9.5%) | 2 |
Productive cough | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 0/15 (0%) | 0 | 1/21 (4.8%) | 2 |
Pulmonary congestion | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Rales | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Respiratory failure | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 2/21 (9.5%) | 2 |
Tachypnoea | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 40 | 1/21 (4.8%) | 40 |
Wheezing | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 4 | 1/21 (4.8%) | 4 |
Skin and subcutaneous tissue disorders | ||||||||
Angioedema | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 2/21 (9.5%) | 2 |
Cold sweat | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 3/15 (20%) | 3 | 3/21 (14.3%) | 3 |
Decubitus ulcer | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Dermal cyst | 1/3 (33.3%) | 4 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/21 (4.8%) | 4 |
Erythema | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 3/15 (20%) | 4 | 5/21 (23.8%) | 6 |
Hyperhidrosis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 4/15 (26.7%) | 14 | 4/21 (19%) | 14 |
Night sweats | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Pruritus | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 2/15 (13.3%) | 3 | 3/21 (14.3%) | 5 |
Rash | 1/3 (33.3%) | 1 | 2/3 (66.7%) | 5 | 1/15 (6.7%) | 1 | 4/21 (19%) | 7 |
Rash macular | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Rash papular | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Rash pruritic | 1/3 (33.3%) | 2 | 1/3 (33.3%) | 1 | 0/15 (0%) | 0 | 2/21 (9.5%) | 3 |
Rosacea | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Skin lesion | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/15 (0%) | 0 | 1/21 (4.8%) | 1 |
Skin mass | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Skin ulcer | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/21 (4.8%) | 1 |
Urticaria | 3/3 (100%) | 8 | 1/3 (33.3%) | 1 | 2/15 (13.3%) | 3 | 6/21 (28.6%) | 12 |
Vascular disorders | ||||||||
Flushing | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 4/15 (26.7%) | 8 | 4/21 (19%) | 8 |
Haematoma | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 2/21 (9.5%) | 2 |
Hot flush | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 4/15 (26.7%) | 4 | 6/21 (28.6%) | 6 |
Hypertension | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 3/15 (20%) | 6 | 3/21 (14.3%) | 6 |
Hypotension | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 3/15 (20%) | 6 | 3/21 (14.3%) | 6 |
Pallor | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 3 | 1/21 (4.8%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title | Debra Lounsbury, Principal Scientist, Clinical Sciences |
---|---|
Organization | BioMarin Pharmaceutical Inc. |
Phone | 415-506-6348 |
DLounsbury@bmrn.com |
- POM-002
- 2011-001805-28