Trial Outcomes & Findings for Extension Study for Patients Who Have Participated in a BMN 701 Study (NCT NCT01435772)
NCT ID: NCT01435772
Last Updated: 2018-05-22
Results Overview
Status of Anti-BMN 701 antibody is corresponding to the test results of blood samples.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Baseline, Week 144
Results posted on
2018-05-22
Participant Flow
Participant milestones
| Measure |
BMN 701 5 mg/kg
IV infusion at dose levels of 5 mg/kg
|
BMN 701 10 mg/kg
IV infusion at dose levels of 10 mg/kg
|
BMN 701 20 mg/kg
IV infusion at dose levels of 20 mg/kg
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
15
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
15
|
Reasons for withdrawal
| Measure |
BMN 701 5 mg/kg
IV infusion at dose levels of 5 mg/kg
|
BMN 701 10 mg/kg
IV infusion at dose levels of 10 mg/kg
|
BMN 701 20 mg/kg
IV infusion at dose levels of 20 mg/kg
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
3
|
|
Overall Study
Other - study termination
|
2
|
2
|
10
|
Baseline Characteristics
Extension Study for Patients Who Have Participated in a BMN 701 Study
Baseline characteristics by cohort
| Measure |
BMN 701 5 mg/kg
n=3 Participants
IV infusion at dose levels of 5 mg/kg
|
BMN 701 10 mg/kg
n=3 Participants
IV infusion at dose levels of 10 mg/kg
|
BMN 701 20 mg/kg
n=15 Participants
IV infusion at dose levels of 20 mg/kg
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 6.66 • n=5 Participants
|
42.7 years
STANDARD_DEVIATION 13.05 • n=7 Participants
|
50.1 years
STANDARD_DEVIATION 5.28 • n=5 Participants
|
49.4 years
STANDARD_DEVIATION 7.03 • n=4 Participants
|
|
Age, Customized
18-65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 144Population: 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.
Status of Anti-BMN 701 antibody is corresponding to the test results of blood samples.
Outcome measures
| Measure |
BMN 701 5 mg/kg
n=3 Participants
IV infusion at dose levels of 5 mg/kg
|
BMN 701 10 mg/kg
n=3 Participants
IV infusion at dose levels of 10 mg/kg
|
BMN 701 20 mg/kg
n=15 Participants
IV infusion at dose levels of 20 mg/kg
|
|---|---|---|---|
|
Number of Participants With a Positive Anti-BMN 701 Antibody
Baseline
|
2 Participants
|
1 Participants
|
11 Participants
|
|
Number of Participants With a Positive Anti-BMN 701 Antibody
Week 144
|
2 Participants
|
2 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 144Population: Full Analysis Set.
Status of Anti-IGF-I antibody is corresponding to the test results of blood samples
Outcome measures
| Measure |
BMN 701 5 mg/kg
n=3 Participants
IV infusion at dose levels of 5 mg/kg
|
BMN 701 10 mg/kg
n=3 Participants
IV infusion at dose levels of 10 mg/kg
|
BMN 701 20 mg/kg
n=15 Participants
IV infusion at dose levels of 20 mg/kg
|
|---|---|---|---|
|
Number of Participants With a Positive Anti-BMN 701 Antibody Response
Baseline
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With a Positive Anti-BMN 701 Antibody Response
Week 144
|
0 Participants
|
1 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 144Population: Full Analysis Set.
Status of Anti-IGF-II antibody is corresponding to the test results of blood samples
Outcome measures
| Measure |
BMN 701 5 mg/kg
n=3 Participants
IV infusion at dose levels of 5 mg/kg
|
BMN 701 10 mg/kg
n=3 Participants
IV infusion at dose levels of 10 mg/kg
|
BMN 701 20 mg/kg
n=15 Participants
IV infusion at dose levels of 20 mg/kg
|
|---|---|---|---|
|
Number of Participants With a Positive Anti-BMN 701 Antibody Response
Baseline
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With a Positive Anti-BMN 701 Antibody Response
Week 144
|
0 Participants
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 144Population: Full Analysis Set. No data collected for outcomes with 0 participants analyzed.
Pulmonary Function Test: Percent Predicted Maximal Inspiratory Pressure
Outcome measures
| Measure |
BMN 701 5 mg/kg
IV infusion at dose levels of 5 mg/kg
|
BMN 701 10 mg/kg
n=3 Participants
IV infusion at dose levels of 10 mg/kg
|
BMN 701 20 mg/kg
n=15 Participants
IV infusion at dose levels of 20 mg/kg
|
|---|---|---|---|
|
Percent Predicted Maximal Inspiratory Pressure (MIP)
Baseline
|
—
|
39.53 Percent of Predicted
Standard Deviation 21.868
|
40.2 Percent of Predicted
Standard Deviation 25.863
|
|
Percent Predicted Maximal Inspiratory Pressure (MIP)
Change from Baseline to Week 144
|
—
|
21.17 Percent of Predicted
Standard Deviation 14.537
|
18.48 Percent of Predicted
Standard Deviation 18.599
|
SECONDARY outcome
Timeframe: Baseline, Week 144Population: Full Analysis Set. No data collected for outcomes with 0 participants analyzed.
Pulmonary Function Test: Percent Predicted Maximum Expiratory Pressure
Outcome measures
| Measure |
BMN 701 5 mg/kg
IV infusion at dose levels of 5 mg/kg
|
BMN 701 10 mg/kg
n=3 Participants
IV infusion at dose levels of 10 mg/kg
|
BMN 701 20 mg/kg
n=15 Participants
IV infusion at dose levels of 20 mg/kg
|
|---|---|---|---|
|
Percent Predicted Maximum Expiratory Pressure (MEP)
Baseline
|
—
|
31.07 Percent of Predicted
Standard Deviation 6.641
|
36.7 Percent of Predicted
Standard Deviation 15.939
|
|
Percent Predicted Maximum Expiratory Pressure (MEP)
Change from Baseline to Week 144
|
—
|
-0.28 Percent of Predicted
Standard Deviation 5.841
|
5.11 Percent of Predicted
Standard Deviation 16.395
|
SECONDARY outcome
Timeframe: Baseline, Week 144Population: Full Analysis Set.
Distance walked within 6 minutes
Outcome measures
| Measure |
BMN 701 5 mg/kg
n=3 Participants
IV infusion at dose levels of 5 mg/kg
|
BMN 701 10 mg/kg
n=3 Participants
IV infusion at dose levels of 10 mg/kg
|
BMN 701 20 mg/kg
n=15 Participants
IV infusion at dose levels of 20 mg/kg
|
|---|---|---|---|
|
6 Minutes Walk Test (Meters)
Baseline
|
334 meter
Standard Deviation 227.119
|
360 meter
Standard Deviation 51.403
|
363.8 meter
Standard Deviation 157.818
|
|
6 Minutes Walk Test (Meters)
Change from Baseline to Week 144
|
-36 meter
Standard Deviation 90.508
|
-120.75 meter
Standard Deviation 67.529
|
9.5 meter
Standard Deviation 77.572
|
SECONDARY outcome
Timeframe: Baseline, Week 144Population: Full Analysis Set. No data collected for outcomes with 0 participants analyzed.
Pulmonary function test: Maximum Voluntary Ventilation (MVV)
Outcome measures
| Measure |
BMN 701 5 mg/kg
IV infusion at dose levels of 5 mg/kg
|
BMN 701 10 mg/kg
n=3 Participants
IV infusion at dose levels of 10 mg/kg
|
BMN 701 20 mg/kg
n=15 Participants
IV infusion at dose levels of 20 mg/kg
|
|---|---|---|---|
|
Maximum Voluntary Ventilation (MVV)
Change from Baseline to Week 144
|
—
|
13.5 L/min
Standard Deviation 13.435
|
2.24 L/min
Standard Deviation 11.635
|
|
Maximum Voluntary Ventilation (MVV)
Baseline
|
—
|
76 L/min
Standard Deviation 41.037
|
68.08 L/min
Standard Deviation 26.74
|
SECONDARY outcome
Timeframe: Baseline, Week 144Population: Full Analysis Set.
Pulmonary function test: Percent Predicted Upright Forced Vital Capacity
Outcome measures
| Measure |
BMN 701 5 mg/kg
n=3 Participants
IV infusion at dose levels of 5 mg/kg
|
BMN 701 10 mg/kg
n=3 Participants
IV infusion at dose levels of 10 mg/kg
|
BMN 701 20 mg/kg
n=15 Participants
IV infusion at dose levels of 20 mg/kg
|
|---|---|---|---|
|
Percent Predicted Upright Forced Vital Capacity (FVC)
Baseline
|
69.33 Percent Predicted
Standard Deviation 19.732
|
67.33 Percent Predicted
Standard Deviation 26.577
|
57.13 Percent Predicted
Standard Deviation 18.677
|
|
Percent Predicted Upright Forced Vital Capacity (FVC)
Change from Baseline to Week 144
|
-8.33 Percent Predicted
Standard Deviation 7.095
|
-0.5 Percent Predicted
Standard Deviation 4.95
|
-2 Percent Predicted
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Baseline, Week 144Population: Full Analysis Set.
Pulmonary function test: Percent Predicted Upright Forced Vital capacity
Outcome measures
| Measure |
BMN 701 5 mg/kg
n=3 Participants
IV infusion at dose levels of 5 mg/kg
|
BMN 701 10 mg/kg
n=3 Participants
IV infusion at dose levels of 10 mg/kg
|
BMN 701 20 mg/kg
n=15 Participants
IV infusion at dose levels of 20 mg/kg
|
|---|---|---|---|
|
Percent Predicted Upright Forced Vital Capacity (FVC)
Baseline
|
36.67 Percent Predicted
Standard Deviation 17.954
|
47.67 Percent Predicted
Standard Deviation 32.578
|
44.25 Percent Predicted
Standard Deviation 21.55
|
|
Percent Predicted Upright Forced Vital Capacity (FVC)
Change from Baseline to Week 144
|
-4.33 Percent Predicted
Standard Deviation 9.452
|
4.5 Percent Predicted
Standard Deviation 26.163
|
-3.43 Percent Predicted
Standard Deviation 6.901
|
SECONDARY outcome
Timeframe: Baseline, Week 144Population: Full Analysis Set. No data collected for outcomes with 0 participants analyzed.
Change from Baseline in Urine Tetrasaccharide Concentration at Week 144
Outcome measures
| Measure |
BMN 701 5 mg/kg
IV infusion at dose levels of 5 mg/kg
|
BMN 701 10 mg/kg
n=2 Participants
IV infusion at dose levels of 10 mg/kg
|
BMN 701 20 mg/kg
n=10 Participants
IV infusion at dose levels of 20 mg/kg
|
|---|---|---|---|
|
Change From Baseline in Urine Tetrasaccharide Concentration at Week 144
|
—
|
-0.2 mmol/mol
Standard Deviation 3.394
|
-1.07 mmol/mol
Standard Deviation 0.975
|
SECONDARY outcome
Timeframe: Baseline, Week 144Population: 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.
Plasma IGF-I concentration from lab
Outcome measures
| Measure |
BMN 701 5 mg/kg
n=2 Participants
IV infusion at dose levels of 5 mg/kg
|
BMN 701 10 mg/kg
n=2 Participants
IV infusion at dose levels of 10 mg/kg
|
BMN 701 20 mg/kg
n=15 Participants
IV infusion at dose levels of 20 mg/kg
|
|---|---|---|---|
|
Plasma IGF-I Concentration
Baseline
|
—
|
—
|
20.26 nmol/L
Standard Deviation 6.465
|
|
Plasma IGF-I Concentration
Week 144
|
26.98 nmol/L
Standard Deviation 1.379
|
18.4 nmol/L
Standard Deviation 7.078
|
17.62 nmol/L
Standard Deviation 5.878
|
SECONDARY outcome
Timeframe: Baseline, Week 144Population: 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.
Plasma IGF-II concentration from lab
Outcome measures
| Measure |
BMN 701 5 mg/kg
n=3 Participants
IV infusion at dose levels of 5 mg/kg
|
BMN 701 10 mg/kg
n=3 Participants
IV infusion at dose levels of 10 mg/kg
|
BMN 701 20 mg/kg
n=15 Participants
IV infusion at dose levels of 20 mg/kg
|
|---|---|---|---|
|
Plasma IGF-II Concentration
Baseline
|
—
|
702 nmol/L
Standard Deviation 0
|
496.83 nmol/L
Standard Deviation 113.417
|
|
Plasma IGF-II Concentration
Week 144
|
467.67 nmol/L
Standard Deviation 117.142
|
559.5 nmol/L
Standard Deviation 140.714
|
698.82 nmol/L
Standard Deviation 228.948
|
SECONDARY outcome
Timeframe: Baseline, Week 144Population: 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.
insulin-like growth factor binding protein 3 from lab
Outcome measures
| Measure |
BMN 701 5 mg/kg
n=3 Participants
IV infusion at dose levels of 5 mg/kg
|
BMN 701 10 mg/kg
n=2 Participants
IV infusion at dose levels of 10 mg/kg
|
BMN 701 20 mg/kg
n=15 Participants
IV infusion at dose levels of 20 mg/kg
|
|---|---|---|---|
|
Insulin-like Growth Factor Binding Protein 3 (IGFBP3)
Baseline
|
—
|
—
|
150.45 nmol/L
Standard Deviation 23.914
|
|
Insulin-like Growth Factor Binding Protein 3 (IGFBP3)
Week 144
|
157.33 nmol/L
Standard Deviation 41.477
|
209 nmol/L
Standard Deviation 39.598
|
146.64 nmol/L
Standard Deviation 33.587
|
Adverse Events
BMN 701 5 mg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
BMN 701 10 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
BMN 701 20 mg/kg
Serious events: 7 serious events
Other events: 15 other events
Deaths: 0 deaths
Total
Serious events: 10 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BMN 701 5 mg/kg
n=3 participants at risk
BMN 701 5 mg/kg
|
BMN 701 10 mg/kg
n=3 participants at risk
BMN 701 10 mg/kg
|
BMN 701 20 mg/kg
n=15 participants at risk
BMN 701 20 mg/kg
|
Total
n=21 participants at risk
Total
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Fatigue
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Immune system disorders
Anaphylactoid reaction
|
33.3%
1/3 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
Other adverse events
| Measure |
BMN 701 5 mg/kg
n=3 participants at risk
BMN 701 5 mg/kg
|
BMN 701 10 mg/kg
n=3 participants at risk
BMN 701 10 mg/kg
|
BMN 701 20 mg/kg
n=15 participants at risk
BMN 701 20 mg/kg
|
Total
n=21 participants at risk
Total
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
20.0%
3/15 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Cardiac disorders
Tachycardia
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
5/15 • Number of events 49 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
7/21 • Number of events 51 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Ear and labyrinth disorders
Vertigo positional
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Endocrine disorders
Androgen deficiency
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Eye disorders
Blindness transient
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Eye disorders
Ocular hyperaemia
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Gastrointestinal disorders
Abdominal discomfort
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 5 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
20.0%
3/15 • Number of events 5 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
23.8%
5/21 • Number of events 7 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Gastrointestinal disorders
Abdominal tenderness
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
20.0%
3/15 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
46.7%
7/15 • Number of events 13 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
7/21 • Number of events 13 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
20.0%
3/15 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
40.0%
6/15 • Number of events 29 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
38.1%
8/21 • Number of events 31 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Gastrointestinal disorders
Painful defaecation
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 5 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 5 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
20.0%
3/15 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Application site erythema
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Asthenia
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Catheter site erythema
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Catheter site inflammation
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Catheter site pain
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Chest discomfort
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
5/15 • Number of events 19 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
28.6%
6/21 • Number of events 20 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Chest pain
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Chills
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
20.0%
3/15 • Number of events 5 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 5 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Discomfort
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Extravasation
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 18 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
53.3%
8/15 • Number of events 16 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
47.6%
10/21 • Number of events 34 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Feeling abnormal
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Feeling cold
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 10 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 11 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Feeling hot
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
20.0%
3/15 • Number of events 7 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
19.0%
4/21 • Number of events 8 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Infusion site extravasation
|
33.3%
1/3 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Infusion site pain
|
66.7%
2/3 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Infusion site swelling
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Malaise
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
26.7%
4/15 • Number of events 5 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
23.8%
5/21 • Number of events 6 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
20.0%
3/15 • Number of events 8 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 8 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Pain
|
66.7%
2/3 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Peripheral swelling
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
20.0%
3/15 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
23.8%
5/21 • Number of events 5 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Pyrexia
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Temperature intolerance
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Tenderness
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
General disorders
Vessel puncture site bruise
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Infections and infestations
Blister infected
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Infections and infestations
Ear infection
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Infections and infestations
Fungal infection
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Infections and infestations
Herpes simplex
|
33.3%
1/3 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Infections and infestations
Influenza
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
20.0%
3/15 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
19.0%
4/21 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Infections and infestations
Lower respiratory tract infection
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
26.7%
4/15 • Number of events 9 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
28.6%
6/21 • Number of events 11 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
26.7%
4/15 • Number of events 7 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
23.8%
5/21 • Number of events 8 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Infections and infestations
Rhinitis
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Infections and infestations
Sinusitis
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
66.7%
2/3 • Number of events 6 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
46.7%
7/15 • Number of events 11 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
47.6%
10/21 • Number of events 20 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Infections and infestations
Viral infection
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Injury, poisoning and procedural complications
Contusion
|
66.7%
2/3 • Number of events 5 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
40.0%
6/15 • Number of events 9 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
42.9%
9/21 • Number of events 15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Injury, poisoning and procedural complications
Fall
|
100.0%
3/3 • Number of events 22 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
66.7%
2/3 • Number of events 5 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
46.7%
7/15 • Number of events 26 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
57.1%
12/21 • Number of events 53 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Injury, poisoning and procedural complications
Laceration
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Injury, poisoning and procedural complications
Muscle strain
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Injury, poisoning and procedural complications
Procedural pain
|
33.3%
1/3 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
66.7%
2/3 • Number of events 5 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
19.0%
4/21 • Number of events 7 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Injury, poisoning and procedural complications
Tendon injury
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Investigations
Ammonia increased
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Investigations
Bacterial test positive
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Investigations
Blood calcium decreased
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Investigations
Blood glucose decreased
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
46.7%
7/15 • Number of events 14 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
7/21 • Number of events 14 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Investigations
Blood immunoglobulin E increased
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Investigations
Cardiac murmur
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Investigations
Complement factor increased
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Investigations
Lipase increased
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Investigations
Pulmonary physical examination abnormal
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Investigations
Troponin increased
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Investigations
Tryptase increased
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
33.3%
1/3 • Number of events 19 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 30 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
93.3%
14/15 • Number of events 106 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
76.2%
16/21 • Number of events 155 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.7%
2/3 • Number of events 8 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
46.7%
7/15 • Number of events 18 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
47.6%
10/21 • Number of events 27 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
100.0%
3/3 • Number of events 6 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
46.7%
7/15 • Number of events 10 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
52.4%
11/21 • Number of events 17 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
20.0%
3/15 • Number of events 9 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
19.0%
4/21 • Number of events 10 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
20.0%
3/15 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
20.0%
3/15 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
53.3%
8/15 • Number of events 14 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
47.6%
10/21 • Number of events 16 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 5 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
53.3%
8/15 • Number of events 11 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
47.6%
10/21 • Number of events 17 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Number of events 7 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
60.0%
9/15 • Number of events 30 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
57.1%
12/21 • Number of events 41 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Nervous system disorders
Hypoaesthesia
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
20.0%
3/15 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
23.8%
5/21 • Number of events 5 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Nervous system disorders
Sciatica
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Nervous system disorders
Sinus headache
|
33.3%
1/3 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Nervous system disorders
Tunnel vision
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Product Issues
Device occlusion
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
19.0%
4/21 • Number of events 5 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Psychiatric disorders
Nervousness
|
33.3%
1/3 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
26.7%
4/15 • Number of events 6 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
28.6%
6/21 • Number of events 11 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Psychiatric disorders
Restlessness
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Psychiatric disorders
Sleep terror
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
20.0%
3/15 • Number of events 8 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 8 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
60.0%
9/15 • Number of events 26 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
47.6%
10/21 • Number of events 27 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
5/15 • Number of events 12 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
7/21 • Number of events 15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 40 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 40 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
20.0%
3/15 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
33.3%
1/3 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
20.0%
3/15 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
23.8%
5/21 • Number of events 6 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
26.7%
4/15 • Number of events 14 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
19.0%
4/21 • Number of events 14 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 5 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
66.7%
2/3 • Number of events 5 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
19.0%
4/21 • Number of events 7 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
33.3%
1/3 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/15 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
100.0%
3/3 • Number of events 8 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
13.3%
2/15 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
28.6%
6/21 • Number of events 12 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
26.7%
4/15 • Number of events 8 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
19.0%
4/21 • Number of events 8 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Vascular disorders
Haematoma
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
9.5%
2/21 • Number of events 2 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Vascular disorders
Hot flush
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
33.3%
1/3 • Number of events 1 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
26.7%
4/15 • Number of events 4 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
28.6%
6/21 • Number of events 6 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
20.0%
3/15 • Number of events 6 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 6 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
20.0%
3/15 • Number of events 6 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
14.3%
3/21 • Number of events 6 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
|
Vascular disorders
Pallor
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
0.00%
0/3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
6.7%
1/15 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
4.8%
1/21 • Number of events 3 • 284.9 weeks (maximum exposure) +4 weeks follow up
|
Additional Information
Debra Lounsbury, Principal Scientist, Clinical Sciences
BioMarin Pharmaceutical Inc.
Phone: 415-506-6348
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place