Trial Outcomes & Findings for Iduronate-2-sulfatase Enzyme Replacement Therapy in Mucopolysaccharidosis II (MPS II) (NCT NCT00069641)
NCT ID: NCT00069641
Last Updated: 2021-06-10
Results Overview
The 2-component composite variable consists of the sum of the ranked changes from baseline to Week 53 for percent predicted Forced Vital Capacity (FVC) and 6-Minute Walking Test (6MWT) total distance walked. For the 2 treatment groups being compared, ranking occurred within the comparison treatment groups combined (idursulfase weekly and placebo treatment groups). These comparison groups were pooled and ranked for each component separately. Within each component (% predicted FVC, 6MWT), the change from baseline was then ranked. The lowest change value was assigned a rank of 1, the next lowest a rank of 2, etc. The composite score for each participant was the sum of the 2 ranked scores corresponding to the 2 individual components (% predicted FVC and 6MWT) for each participant. Thus, the greater the composite score (greater the sum of the ranks of the changes from baseline, where the lowest change was ranked as 1), the greater the improvement.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
96 participants
Primary outcome timeframe
Baseline, Week 53
Results posted on
2021-06-10
Participant Flow
Participant milestones
| Measure |
Idursulfase Weekly (0.5 mg/kg)
Idursulfase 0.5 milligram per kilogram (mg/kg) administered once-weekly by intravenous infusion for one year (52 infusions).
|
Idursulfase Every Other Week (EOW) (0.5 mg/kg)
Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
|
Placebo
Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
32
|
|
Overall Study
COMPLETED
|
31
|
32
|
31
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Idursulfase Weekly (0.5 mg/kg)
Idursulfase 0.5 milligram per kilogram (mg/kg) administered once-weekly by intravenous infusion for one year (52 infusions).
|
Idursulfase Every Other Week (EOW) (0.5 mg/kg)
Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
|
Placebo
Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
1
|
Baseline Characteristics
Iduronate-2-sulfatase Enzyme Replacement Therapy in Mucopolysaccharidosis II (MPS II)
Baseline characteristics by cohort
| Measure |
Idursulfase Weekly (0.5 mg/kg)
n=32 Participants
Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
|
Idursulfase EOW (0.5 mg/kg)
n=32 Participants
Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
|
Placebo
n=32 Participants
Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
15.14 years
STANDARD_DEVIATION 6.293 • n=5 Participants
|
14.40 years
STANDARD_DEVIATION 7.019 • n=7 Participants
|
13.12 years
STANDARD_DEVIATION 6.908 • n=5 Participants
|
14.22 years
STANDARD_DEVIATION 6.729 • n=4 Participants
|
|
Age, Customized
5 to 11 years
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Age, Customized
12 to 18 years
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Age, Customized
19 to 25 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Age, Customized
greater than equal to (>=) 26 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Region of Enrollment
North America
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Region of Enrollment
South America
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Region of Enrollment
Europe
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 53Population: Intent-to-treat (ITT) population, Only participants receiving "Idursulfase Weekly" or "Placebo" were to be analyzed for this outcome.
The 2-component composite variable consists of the sum of the ranked changes from baseline to Week 53 for percent predicted Forced Vital Capacity (FVC) and 6-Minute Walking Test (6MWT) total distance walked. For the 2 treatment groups being compared, ranking occurred within the comparison treatment groups combined (idursulfase weekly and placebo treatment groups). These comparison groups were pooled and ranked for each component separately. Within each component (% predicted FVC, 6MWT), the change from baseline was then ranked. The lowest change value was assigned a rank of 1, the next lowest a rank of 2, etc. The composite score for each participant was the sum of the 2 ranked scores corresponding to the 2 individual components (% predicted FVC and 6MWT) for each participant. Thus, the greater the composite score (greater the sum of the ranks of the changes from baseline, where the lowest change was ranked as 1), the greater the improvement.
Outcome measures
| Measure |
Idursulfase Weekly (0.5 mg/kg)
n=32 Participants
Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
|
Idursulfase EOW (0.5 mg/kg)
n=32 Participants
Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
|
Placebo
Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
|
|---|---|---|---|
|
Ranked Adjusted 2-Component Composite Variable Score Based on Change From Baseline to Week 53
|
69.81 sum of the ranked scores
Standard Error 7.03
|
50.86 sum of the ranked scores
Standard Error 8.07
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 53Population: ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.
Change was calculated at Week 53 from baseline. Global JROM (% of normal range of motion) is the average of 11 ratios multiplied by 100. Ratios are Left/Right means of passive range of motion in Shoulder (Flexion/Extension, Abduction, Internal/External Rotation), Elbow (Flexion/Extension), Wrist (Flexion/Extension), Index Finger (Flexion/Extension \[Combined Metacarpophalangeal joint (MCP), Proximal interphalangeal joint (PIP), Distal interphalangeal joint (DIP) motion\]), Hip (Flexion/Extension, Abduction, Internal/External Rotation), Knee (Flexion/Extension), and Ankle (Dorsiflexion) divided by the normal range (American Academy of Orthopedic Surgeons and American Medical Association).
Outcome measures
| Measure |
Idursulfase Weekly (0.5 mg/kg)
n=31 Participants
Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
|
Idursulfase EOW (0.5 mg/kg)
n=32 Participants
Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
|
Placebo
n=31 Participants
Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
|
|---|---|---|---|
|
Change From Baseline in Mean Global Joint Range of Motion (JROM) Score at Week 53
Change at Week 53
|
0.89 percentage of normal range of motion
Standard Error 0.87
|
-0.61 percentage of normal range of motion
Standard Error 0.94
|
0.70 percentage of normal range of motion
Standard Error 1.10
|
|
Change From Baseline in Mean Global Joint Range of Motion (JROM) Score at Week 53
Baseline
|
66.86 percentage of normal range of motion
Standard Error 1.85
|
67.36 percentage of normal range of motion
Standard Error 1.43
|
67.70 percentage of normal range of motion
Standard Error 1.59
|
SECONDARY outcome
Timeframe: BaselinePopulation: ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.
Liver and Spleen volume was determined by Magnetic Resonance Imaging (MRI).
Outcome measures
| Measure |
Idursulfase Weekly (0.5 mg/kg)
n=31 Participants
Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
|
Idursulfase EOW (0.5 mg/kg)
n=29 Participants
Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
|
Placebo
n=30 Participants
Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
|
|---|---|---|---|
|
Mean Combined Liver and Spleen Volume at Baseline
|
1578.48 milliliter (mL)
Standard Error 80.75
|
1442.2 milliliter (mL)
Standard Error 63.54
|
1485.28 milliliter (mL)
Standard Error 70.19
|
SECONDARY outcome
Timeframe: Baseline, Week 53Population: ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.
Liver and Spleen volume was determined by Magnetic Resonance Imaging (MRI). Change was calculated at Week 53 from baseline.
Outcome measures
| Measure |
Idursulfase Weekly (0.5 mg/kg)
n=31 Participants
Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
|
Idursulfase EOW (0.5 mg/kg)
n=29 Participants
Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
|
Placebo
n=30 Participants
Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
|
|---|---|---|---|
|
Percent Change From Baseline in Mean Combined Liver and Spleen Volume at Week 53
|
-25.81 percent change
Standard Error 1.44
|
-23.73 percent change
Standard Error 1.49
|
0.27 percent change
Standard Error 1.66
|
SECONDARY outcome
Timeframe: Baseline, Week 53Population: ITT population.
Mean normalized urine GAG was analyzed using urine testing. Change was calculated at Week 53 from baseline. The urine GAG levels were normalized to urine creatinine and were reported as microgram GAG per milligram creatinine (mcg GAG/mg creatinine).
Outcome measures
| Measure |
Idursulfase Weekly (0.5 mg/kg)
n=32 Participants
Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
|
Idursulfase EOW (0.5 mg/kg)
n=32 Participants
Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
|
Placebo
n=32 Participants
Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
|
|---|---|---|---|
|
Change From Baseline in Mean Normalized Urine Glycosaminoglycan (GAG) Levels at Week 53
Baseline
|
325.59 mcg GAG/mg creatinine
Standard Error 25.79
|
338.08 mcg GAG/mg creatinine
Standard Error 21.03
|
419.40 mcg GAG/mg creatinine
Standard Error 34.37
|
|
Change From Baseline in Mean Normalized Urine Glycosaminoglycan (GAG) Levels at Week 53
Change at Week 53
|
-189.23 mcg GAG/mg creatinine
Standard Error 25.76
|
-154.98 mcg GAG/mg creatinine
Standard Error 17.18
|
18.16 mcg GAG/mg creatinine
Standard Error 29.94
|
SECONDARY outcome
Timeframe: BaselinePopulation: ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.
Cardiac LVMI was determined by echocardiography. LVMI is the left ventricular mass (LVM, in grams \[g\]) indexed to body surface area (BSA), in square meter \[m\^2\]. LVMI (in gram per square meter \[g/m\^2\]) = LVM divided by BSA.
Outcome measures
| Measure |
Idursulfase Weekly (0.5 mg/kg)
n=31 Participants
Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
|
Idursulfase EOW (0.5 mg/kg)
n=31 Participants
Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
|
Placebo
n=31 Participants
Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
|
|---|---|---|---|
|
Mean Cardiac Left Ventricular Mass Index (LVMI) at Baseline
|
105.18 gram per square meter (g/m^2)
Standard Error 6.86
|
89.42 gram per square meter (g/m^2)
Standard Error 4.38
|
95.55 gram per square meter (g/m^2)
Standard Error 5.96
|
SECONDARY outcome
Timeframe: Baseline, Week 53Population: ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.
Cardiac LVMI was determined by echocardiography. Change was calculated at Week 53 from baseline. LVMI is the LVM, in grams indexed to BSA, in square meter \[m\^2\]. LVMI in g/m\^2 = LVM divided by BSA.
Outcome measures
| Measure |
Idursulfase Weekly (0.5 mg/kg)
n=31 Participants
Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
|
Idursulfase EOW (0.5 mg/kg)
n=31 Participants
Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
|
Placebo
n=31 Participants
Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
|
|---|---|---|---|
|
Percent Change From Baseline in Mean Cardiac Left Ventricular Mass Index (LVMI) at Week 53
|
-1.34 percent change
Standard Error 5.05
|
6.71 percent change
Standard Error 4.03
|
3.56 percent change
Standard Error 4.12
|
Adverse Events
Idursulfase Weekly (0.5 mg/kg)
Serious events: 9 serious events
Other events: 32 other events
Deaths: 0 deaths
Idursulfase EOW (0.5 mg/kg)
Serious events: 8 serious events
Other events: 32 other events
Deaths: 0 deaths
Placebo
Serious events: 9 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Idursulfase Weekly (0.5 mg/kg)
n=32 participants at risk
Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
|
Idursulfase EOW (0.5 mg/kg)
n=32 participants at risk
Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
|
Placebo
n=32 participants at risk
Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Rash nos
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Vascular disorders
Poor venous access
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
9.4%
3/32 • Number of events 4 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
|
Psychiatric disorders
Phobia
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm nos
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Cardiac disorders
Aortic valve incompetence
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Cardiac disorders
Arrhythmia not otherwise specified (nos)
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Cardiac disorders
Atrial tachycardia
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Cardiac disorders
Cyanosis nos
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Cardiac disorders
Heart valve insufficiency
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Ear and labyrinth disorders
Ear disorder nos
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Ear and labyrinth disorders
Otorrhoea
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Umbilical hernia nos
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
General disorders
Hernia nos
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Infections and infestations
Bronchopneumonia nos
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Infections and infestations
Localised infection
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Infections and infestations
Otitis media chronic nos
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
|
Infections and infestations
Otitis media serous nos
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Infections and infestations
Pilonidal sinus infected
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Tooth caries nos
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Infections and infestations
Wound infection due to staphylococcus aureus
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Injury, poisoning and procedural complications
Anaesthesia intubation complication
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Injury, poisoning and procedural complications
Medical device complication
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Investigations
Blood carbon dioxide increased
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Nervous system disorders
Carpal tunnel syndrome
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
Other adverse events
| Measure |
Idursulfase Weekly (0.5 mg/kg)
n=32 participants at risk
Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
|
Idursulfase EOW (0.5 mg/kg)
n=32 participants at risk
Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
|
Placebo
n=32 participants at risk
Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Cardiac disorders
Atrial hypertrophy
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
|
Cardiac disorders
Tachycardia nos
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
9.4%
3/32 • Number of events 5 • 52 weeks
|
6.2%
2/32 • Number of events 10 • 52 weeks
|
|
Cardiac disorders
Ventricular hypertrophy
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
|
Ear and labyrinth disorders
Deafness nos
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Ear and labyrinth disorders
Ear disorder nos
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
21.9%
7/32 • Number of events 7 • 52 weeks
|
15.6%
5/32 • Number of events 9 • 52 weeks
|
18.8%
6/32 • Number of events 13 • 52 weeks
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
6.2%
2/32 • Number of events 5 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Ear and labyrinth disorders
Hypoacusis
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
15.6%
5/32 • Number of events 5 • 52 weeks
|
12.5%
4/32 • Number of events 5 • 52 weeks
|
|
Ear and labyrinth disorders
Otorrhoea
|
21.9%
7/32 • Number of events 20 • 52 weeks
|
21.9%
7/32 • Number of events 17 • 52 weeks
|
28.1%
9/32 • Number of events 21 • 52 weeks
|
|
Ear and labyrinth disorders
Sensation of block in ear
|
0.00%
0/32 • 52 weeks
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
|
Eye disorders
Conjunctivitis
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
|
Eye disorders
Conjunctivitis allergic
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Eye disorders
Eye pain
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Eye disorders
Hypermetropia
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Eye disorders
Lacrimation increased
|
9.4%
3/32 • Number of events 6 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 2 • 52 weeks
|
|
Eye disorders
Myopia
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Eye disorders
Vision blurred
|
9.4%
3/32 • Number of events 5 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain nos
|
34.4%
11/32 • Number of events 24 • 52 weeks
|
53.1%
17/32 • Number of events 36 • 52 weeks
|
34.4%
11/32 • Number of events 20 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
15.6%
5/32 • Number of events 14 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
|
Gastrointestinal disorders
Constipation
|
6.2%
2/32 • Number of events 4 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
3.1%
1/32 • Number of events 2 • 52 weeks
|
|
Gastrointestinal disorders
Diarrhoea nos
|
34.4%
11/32 • Number of events 22 • 52 weeks
|
37.5%
12/32 • Number of events 24 • 52 weeks
|
46.9%
15/32 • Number of events 29 • 52 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
4/32 • Number of events 5 • 52 weeks
|
12.5%
4/32 • Number of events 18 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 13 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Gastroenteritis nos
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
9.4%
3/32 • Number of events 4 • 52 weeks
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Gastrointestinal disorders
Inguinal hernia nos
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
|
Gastrointestinal disorders
Loose stools
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 4 • 52 weeks
|
|
Gastrointestinal disorders
Nausea
|
21.9%
7/32 • Number of events 18 • 52 weeks
|
28.1%
9/32 • Number of events 16 • 52 weeks
|
28.1%
9/32 • Number of events 17 • 52 weeks
|
|
Gastrointestinal disorders
Swollen tongue
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Gastrointestinal disorders
Toothache
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
|
Gastrointestinal disorders
Umbilical hernia nos
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Vomiting nos
|
25.0%
8/32 • Number of events 22 • 52 weeks
|
56.2%
18/32 • Number of events 37 • 52 weeks
|
50.0%
16/32 • Number of events 43 • 52 weeks
|
|
General disorders
Asthenia
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
General disorders
Catheter site pain
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
|
General disorders
Chest pain
|
9.4%
3/32 • Number of events 7 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
General disorders
Fall
|
0.00%
0/32 • 52 weeks
|
12.5%
4/32 • Number of events 7 • 52 weeks
|
12.5%
4/32 • Number of events 10 • 52 weeks
|
|
General disorders
Fatigue
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
12.5%
4/32 • Number of events 10 • 52 weeks
|
9.4%
3/32 • Number of events 5 • 52 weeks
|
|
General disorders
Gait abnormal
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
|
General disorders
Hernia pain
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
3.1%
1/32 • Number of events 2 • 52 weeks
|
|
General disorders
Inflammation localised
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
General disorders
Influenza like illness
|
9.4%
3/32 • Number of events 7 • 52 weeks
|
25.0%
8/32 • Number of events 12 • 52 weeks
|
12.5%
4/32 • Number of events 6 • 52 weeks
|
|
General disorders
Infusion site pain
|
9.4%
3/32 • Number of events 5 • 52 weeks
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
|
General disorders
Infusion site swelling
|
12.5%
4/32 • Number of events 6 • 52 weeks
|
12.5%
4/32 • Number of events 4 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
General disorders
Injection site bruising
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
General disorders
Injection site extravasation
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
|
General disorders
Injection site haemorrhage
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
|
General disorders
Lethargy
|
6.2%
2/32 • Number of events 4 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
General disorders
Malaise
|
15.6%
5/32 • Number of events 7 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
|
General disorders
Oedema peripheral
|
6.2%
2/32 • Number of events 11 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
General disorders
Pain nos
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
|
General disorders
Pyrexia
|
62.5%
20/32 • Number of events 83 • 52 weeks
|
56.2%
18/32 • Number of events 68 • 52 weeks
|
59.4%
19/32 • Number of events 63 • 52 weeks
|
|
General disorders
Rigors
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
9.4%
3/32 • Number of events 8 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
General disorders
Sensation of foreign body nos
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Infections and infestations
Ear infection nos
|
25.0%
8/32 • Number of events 15 • 52 weeks
|
28.1%
9/32 • Number of events 17 • 52 weeks
|
28.1%
9/32 • Number of events 19 • 52 weeks
|
|
Infections and infestations
Furuncle
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Herpes simplex
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
3.1%
1/32 • Number of events 4 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Infections and infestations
Hordeolum
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
|
Infections and infestations
Influenza
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
3.1%
1/32 • Number of events 2 • 52 weeks
|
|
Infections and infestations
Lice infestation
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
|
Infections and infestations
Localised infection
|
0.00%
0/32 • 52 weeks
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Infections and infestations
Lower respiratory tract infection nos
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Otitis media nos
|
18.8%
6/32 • Number of events 8 • 52 weeks
|
21.9%
7/32 • Number of events 11 • 52 weeks
|
21.9%
7/32 • Number of events 9 • 52 weeks
|
|
Infections and infestations
Otitis media serous nos
|
12.5%
4/32 • Number of events 8 • 52 weeks
|
6.2%
2/32 • Number of events 7 • 52 weeks
|
12.5%
4/32 • Number of events 6 • 52 weeks
|
|
Infections and infestations
Respiratory tract infection nos
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Sinusitis nos
|
15.6%
5/32 • Number of events 5 • 52 weeks
|
6.2%
2/32 • Number of events 5 • 52 weeks
|
9.4%
3/32 • Number of events 4 • 52 weeks
|
|
Infections and infestations
Tonsillitis
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Tracheobronchitis
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
9.4%
3/32 • Number of events 4 • 52 weeks
|
|
Infections and infestations
Upper respiratory tract infection nos
|
37.5%
12/32 • Number of events 26 • 52 weeks
|
37.5%
12/32 • Number of events 34 • 52 weeks
|
31.2%
10/32 • Number of events 19 • 52 weeks
|
|
Infections and infestations
Urinary tract infection nos
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Infections and infestations
Varicella
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Infections and infestations
Viral infection nos
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
|
Injury, poisoning and procedural complications
Abrasion nos
|
0.00%
0/32 • 52 weeks
|
9.4%
3/32 • Number of events 6 • 52 weeks
|
9.4%
3/32 • Number of events 6 • 52 weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
9.4%
3/32 • Number of events 5 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/32 • 52 weeks
|
12.5%
4/32 • Number of events 5 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Injury, poisoning and procedural complications
Post procedural pain
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
9.4%
3/32 • Number of events 5 • 52 weeks
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
12.5%
4/32 • Number of events 6 • 52 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
|
Investigations
Blood alkaline phosphatase nos increased
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
|
Investigations
Blood lactate dehydrogenase increased
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Investigations
Electrocardiogram abnormal nos
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Investigations
Gamma-Glutamyltransferase increased
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
|
Investigations
Haematocrit decreased
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
|
Investigations
Haemoglobin decreased
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
|
Metabolism and nutrition disorders
Appetite decreased nos
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
3.1%
1/32 • Number of events 3 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
31.2%
10/32 • Number of events 26 • 52 weeks
|
43.8%
14/32 • Number of events 28 • 52 weeks
|
28.1%
9/32 • Number of events 15 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
8/32 • Number of events 10 • 52 weeks
|
34.4%
11/32 • Number of events 25 • 52 weeks
|
25.0%
8/32 • Number of events 11 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
12.5%
4/32 • Number of events 4 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
6.2%
2/32 • Number of events 4 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
9.4%
3/32 • Number of events 4 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
12.5%
4/32 • Number of events 8 • 52 weeks
|
9.4%
3/32 • Number of events 4 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.4%
3/32 • Number of events 4 • 52 weeks
|
12.5%
4/32 • Number of events 4 • 52 weeks
|
9.4%
3/32 • Number of events 7 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in foot
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
3.1%
1/32 • Number of events 3 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in limb
|
28.1%
9/32 • Number of events 20 • 52 weeks
|
28.1%
9/32 • Number of events 18 • 52 weeks
|
31.2%
10/32 • Number of events 14 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Peripheral swelling
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
12.5%
4/32 • Number of events 4 • 52 weeks
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
|
Nervous system disorders
Carpal tunnel syndrome
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Nervous system disorders
Dizziness
|
12.5%
4/32 • Number of events 10 • 52 weeks
|
18.8%
6/32 • Number of events 9 • 52 weeks
|
25.0%
8/32 • Number of events 16 • 52 weeks
|
|
Nervous system disorders
Headache
|
59.4%
19/32 • Number of events 132 • 52 weeks
|
65.6%
21/32 • Number of events 118 • 52 weeks
|
43.8%
14/32 • Number of events 80 • 52 weeks
|
|
Nervous system disorders
Hyperreflexia
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
|
Nervous system disorders
Insomnia
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
9.4%
3/32 • Number of events 22 • 52 weeks
|
3.1%
1/32 • Number of events 3 • 52 weeks
|
|
Nervous system disorders
Migraine nos
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 3 • 52 weeks
|
|
Nervous system disorders
Paraesthesia
|
6.2%
2/32 • Number of events 6 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
3.1%
1/32 • Number of events 3 • 52 weeks
|
|
Nervous system disorders
Post-Traumatic headache
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Nervous system disorders
Somnolence
|
0.00%
0/32 • 52 weeks
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Nervous system disorders
Tremor
|
6.2%
2/32 • Number of events 4 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Psychiatric disorders
Abnormal behaviour nos
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
|
Psychiatric disorders
Anxiety
|
6.2%
2/32 • Number of events 4 • 52 weeks
|
12.5%
4/32 • Number of events 5 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Psychiatric disorders
Depression
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Renal and urinary disorders
Haematuria
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma nos
|
9.4%
3/32 • Number of events 4 • 52 weeks
|
3.1%
1/32 • Number of events 3 • 52 weeks
|
6.2%
2/32 • Number of events 4 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis nos
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm nos
|
9.4%
3/32 • Number of events 5 • 52 weeks
|
6.2%
2/32 • Number of events 5 • 52 weeks
|
12.5%
4/32 • Number of events 11 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
16/32 • Number of events 30 • 52 weeks
|
50.0%
16/32 • Number of events 38 • 52 weeks
|
59.4%
19/32 • Number of events 42 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea nos
|
12.5%
4/32 • Number of events 10 • 52 weeks
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
28.1%
9/32 • Number of events 11 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
3.1%
1/32 • Number of events 5 • 52 weeks
|
12.5%
4/32 • Number of events 5 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.1%
1/32 • Number of events 2 • 52 weeks
|
9.4%
3/32 • Number of events 4 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
37.5%
12/32 • Number of events 18 • 52 weeks
|
50.0%
16/32 • Number of events 39 • 52 weeks
|
37.5%
12/32 • Number of events 23 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal passage irritation
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
12.5%
4/32 • Number of events 5 • 52 weeks
|
25.0%
8/32 • Number of events 16 • 52 weeks
|
15.6%
5/32 • Number of events 15 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder nos
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
40.6%
13/32 • Number of events 19 • 52 weeks
|
34.4%
11/32 • Number of events 23 • 52 weeks
|
31.2%
10/32 • Number of events 18 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic nos
|
9.4%
3/32 • Number of events 7 • 52 weeks
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
9.4%
3/32 • Number of events 6 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis nos
|
12.5%
4/32 • Number of events 5 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
12.5%
4/32 • Number of events 4 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
28.1%
9/32 • Number of events 14 • 52 weeks
|
31.2%
10/32 • Number of events 19 • 52 weeks
|
28.1%
9/32 • Number of events 20 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
12.5%
4/32 • Number of events 4 • 52 weeks
|
15.6%
5/32 • Number of events 9 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
9.4%
3/32 • Number of events 4 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
6.2%
2/32 • Number of events 4 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
15.6%
5/32 • Number of events 6 • 52 weeks
|
15.6%
5/32 • Number of events 7 • 52 weeks
|
15.6%
5/32 • Number of events 8 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Acne nos
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Contusion
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
15.6%
5/32 • Number of events 6 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Dyshidrosis
|
0.00%
0/32 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 2 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
2/32 • Number of events 12 • 52 weeks
|
3.1%
1/32 • Number of events 3 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
31.2%
10/32 • Number of events 19 • 52 weeks
|
18.8%
6/32 • Number of events 14 • 52 weeks
|
15.6%
5/32 • Number of events 10 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
3.1%
1/32 • Number of events 1 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Rash nos
|
25.0%
8/32 • Number of events 14 • 52 weeks
|
34.4%
11/32 • Number of events 39 • 52 weeks
|
31.2%
10/32 • Number of events 29 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
15.6%
5/32 • Number of events 9 • 52 weeks
|
15.6%
5/32 • Number of events 6 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Sweating increased
|
6.2%
2/32 • Number of events 3 • 52 weeks
|
6.2%
2/32 • Number of events 2 • 52 weeks
|
9.4%
3/32 • Number of events 3 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria nos
|
15.6%
5/32 • Number of events 10 • 52 weeks
|
12.5%
4/32 • Number of events 9 • 52 weeks
|
0.00%
0/32 • 52 weeks
|
|
Vascular disorders
Flushing
|
15.6%
5/32 • Number of events 9 • 52 weeks
|
15.6%
5/32 • Number of events 9 • 52 weeks
|
18.8%
6/32 • Number of events 7 • 52 weeks
|
|
Vascular disorders
Hypertension nos
|
25.0%
8/32 • Number of events 23 • 52 weeks
|
15.6%
5/32 • Number of events 7 • 52 weeks
|
21.9%
7/32 • Number of events 10 • 52 weeks
|
|
Vascular disorders
Hypotension nos
|
9.4%
3/32 • Number of events 5 • 52 weeks
|
6.2%
2/32 • Number of events 4 • 52 weeks
|
12.5%
4/32 • Number of events 9 • 52 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60