Trial Outcomes & Findings for A Study Evaluating the Safety and Pharmacokinetics of Aldurazyme® (Laronidase) in MPS I Patients Less Than 5 Years Old (NCT NCT00146757)
NCT ID: NCT00146757
Last Updated: 2015-04-03
Results Overview
Overall Safety Summary of Adverse Events (AEs) during Treatment Safety assessment was based on the incidence of AE reports.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
52 weeks
Results posted on
2015-04-03
Participant Flow
Participant milestones
| Measure |
Aldurazyme (rhIDU) 100 U/kg Every Week
Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks - labeled dose.
|
Aldurazyme (rhIDU) 100-200 U/kg Every Week
After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient's urinary glycosaminoglycan (uGAG) levels were \>200µg/mg creatinine at Week 22.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
4
|
|
Overall Study
COMPLETED
|
14
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Aldurazyme (rhIDU) 100 U/kg Every Week
Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks - labeled dose.
|
Aldurazyme (rhIDU) 100-200 U/kg Every Week
After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient's urinary glycosaminoglycan (uGAG) levels were \>200µg/mg creatinine at Week 22.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Study Evaluating the Safety and Pharmacokinetics of Aldurazyme® (Laronidase) in MPS I Patients Less Than 5 Years Old
Baseline characteristics by cohort
| Measure |
Arms 1 and 2 Combined
n=20 Participants
|
|---|---|
|
Age, Continuous
|
2.9 years
STANDARD_DEVIATION 1.48 • n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
18 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: The number of participants was determined as adequate to assess the safety of Aldurazyme in young children with mucopolysaccharidosis I (MPS I). The analysis was intent-to-treat.
Overall Safety Summary of Adverse Events (AEs) during Treatment Safety assessment was based on the incidence of AE reports.
Outcome measures
| Measure |
Aldurazyme (rhIDU) 100 U/kg Every Week
n=16 Participants
Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks - labeled dose.
|
Aldurazyme (rhIDU) 100-200 U/kg Every Week
n=4 Participants
After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient's urinary glycosaminoglycan (uGAG) levels were \>200µg/mg creatinine at Week 22.
|
|---|---|---|
|
Safety Evaluation
Having Adverse Events (AE)
|
16 participants
21.41
|
4 participants
14.21
|
|
Safety Evaluation
Having Drug-Related AEs
|
5 participants
|
3 participants
|
|
Safety Evaluation
Deaths/Discontinuations Due to AEs
|
2 participants
|
0 participants
|
|
Safety Evaluation
Having Serious AEs
|
12 participants
|
3 participants
|
|
Safety Evaluation
Having Infusion Associated Reactions (IAR):
|
4 participants
|
3 participants
|
|
Safety Evaluation
Having Severe AEs
|
5 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: The analysis was intent-to-treat.
AUC∞ is a measure of the total exposure to a drug.
Outcome measures
| Measure |
Aldurazyme (rhIDU) 100 U/kg Every Week
n=20 Participants
Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks - labeled dose.
|
Aldurazyme (rhIDU) 100-200 U/kg Every Week
After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient's urinary glycosaminoglycan (uGAG) levels were \>200µg/mg creatinine at Week 22.
|
|---|---|---|
|
Pharmacokinetics - Area Under the (Plasma Concentration-time) Curve (AUC∞)
Week 1
|
0.577 hours units/milliliters
Standard Deviation 0.591
|
—
|
|
Pharmacokinetics - Area Under the (Plasma Concentration-time) Curve (AUC∞)
Week 13
|
0.418 hours units/milliliters
Standard Deviation 0.246
|
—
|
|
Pharmacokinetics - Area Under the (Plasma Concentration-time) Curve (AUC∞)
Week 26
|
0.92 hours units/milliliters
Standard Deviation 0.68
|
—
|
|
Pharmacokinetics - Area Under the (Plasma Concentration-time) Curve (AUC∞)
Week 52
|
0.94 hours units/milliliters
Standard Deviation 0.97
|
—
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: The analysis was intent-to-treat.
Half-life is the time it takes for the concentration of drug in plasma to decline by 50%.
Outcome measures
| Measure |
Aldurazyme (rhIDU) 100 U/kg Every Week
n=20 Participants
Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks - labeled dose.
|
Aldurazyme (rhIDU) 100-200 U/kg Every Week
After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient's urinary glycosaminoglycan (uGAG) levels were \>200µg/mg creatinine at Week 22.
|
|---|---|---|
|
Pharmacokinetics - Elimination Half Life (t1/2)
Week 1
|
1.55 hours
Standard Deviation 0.516
|
—
|
|
Pharmacokinetics - Elimination Half Life (t1/2)
Week 13
|
0.55 hours
Standard Deviation 0.284
|
—
|
|
Pharmacokinetics - Elimination Half Life (t1/2)
Week 26
|
0.946 hours
Standard Deviation 0.877
|
—
|
|
Pharmacokinetics - Elimination Half Life (t1/2)
Week 52
|
1.147 hours
Standard Deviation 0.87
|
—
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: The analysis was intent-to-treat.
CL is volume of the body fluid cleared of the drug per unit of time.
Outcome measures
| Measure |
Aldurazyme (rhIDU) 100 U/kg Every Week
n=20 Participants
Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks - labeled dose.
|
Aldurazyme (rhIDU) 100-200 U/kg Every Week
After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient's urinary glycosaminoglycan (uGAG) levels were \>200µg/mg creatinine at Week 22.
|
|---|---|---|
|
Pharmacokinetics - Total Plasma Clearance (CL)
Week 1
|
5.73 (milliliters/minute)/kilograms
Standard Deviation 3.90
|
—
|
|
Pharmacokinetics - Total Plasma Clearance (CL)
Week 13
|
5.33 (milliliters/minute)/kilograms
Standard Deviation 2.67
|
—
|
|
Pharmacokinetics - Total Plasma Clearance (CL)
Week 26
|
2.97 (milliliters/minute)/kilograms
Standard Deviation 1.87
|
—
|
|
Pharmacokinetics - Total Plasma Clearance (CL)
Week 52
|
3.20 (milliliters/minute)/kilograms
Standard Deviation 2.02
|
—
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: The analysis was intent-to-treat.
Vz is the volume that relates the amount of drug in the body after absorption is complete to the concentration of drug in the plasma.
Outcome measures
| Measure |
Aldurazyme (rhIDU) 100 U/kg Every Week
n=20 Participants
Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks - labeled dose.
|
Aldurazyme (rhIDU) 100-200 U/kg Every Week
After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient's urinary glycosaminoglycan (uGAG) levels were \>200µg/mg creatinine at Week 22.
|
|---|---|---|
|
Pharmacokinetics - Volume of Distribution (Vz)
Week 1
|
0.753 liters/kilograms
Standard Deviation 0.497
|
—
|
|
Pharmacokinetics - Volume of Distribution (Vz)
Week 13
|
0.299 liters/kilograms
Standard Deviation 0.303
|
—
|
|
Pharmacokinetics - Volume of Distribution (Vz)
Week 52
|
0.246 liters/kilograms
Standard Deviation 0.210
|
—
|
|
Pharmacokinetics - Volume of Distribution (Vz)
Week 26
|
0.214 liters/kilograms
Standard Deviation 0.297
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 52 weeksPopulation: The analysis was intent-to-treat.
Percentage change in the concentration of GAG relative to creatinine (ug GAG/mg creatinine) in urine from Baseline to Week 52; A greater decrease in percent change indicates a greater response.
Outcome measures
| Measure |
Aldurazyme (rhIDU) 100 U/kg Every Week
n=12 Participants
Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks - labeled dose.
|
Aldurazyme (rhIDU) 100-200 U/kg Every Week
n=4 Participants
After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient's urinary glycosaminoglycan (uGAG) levels were \>200µg/mg creatinine at Week 22.
|
|---|---|---|
|
Percent Change From Baseline to Week 52 in Urinary Glycosaminoglycan (uGAG) Level
|
-59.1 Percentage of change
Standard Deviation 21.41
|
-67.7 Percentage of change
Standard Deviation 14.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 52 weeksPopulation: The analysis was intent-to-treat.
Percent change in extent of Liver Edge Below Right Costal Margin (BRCM) measured in centimeters from Baseline to Week 52; A greater decrease in percent change indicates a greater response.
Outcome measures
| Measure |
Aldurazyme (rhIDU) 100 U/kg Every Week
n=10 Participants
Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks - labeled dose.
|
Aldurazyme (rhIDU) 100-200 U/kg Every Week
After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient's urinary glycosaminoglycan (uGAG) levels were \>200µg/mg creatinine at Week 22.
|
|---|---|---|
|
Percent Change From Baseline to Week 52 in Liver Size (Hepatomegaly)
|
-69.5 Percentage of change
Standard Deviation 15.34
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 52 weeksPopulation: The analysis was intent-to-treat.
Number of absent (apnea) and shallow (hypopnea) breaths per hour of sleep. A greater decrease in events per hour indicates a greater response.
Outcome measures
| Measure |
Aldurazyme (rhIDU) 100 U/kg Every Week
n=14 Participants
Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks - labeled dose.
|
Aldurazyme (rhIDU) 100-200 U/kg Every Week
After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient's urinary glycosaminoglycan (uGAG) levels were \>200µg/mg creatinine at Week 22.
|
|---|---|---|
|
Change From Baseline to Week 52 in Apnea/Hypopnea Index (AHI)
|
-2.6 Events per hour
Standard Deviation 22.27
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 52 weeksPopulation: The analysis was intent-to-treat.
Independent experts provided a global assessment for each sleep study visit as well as the degree of clinically meaningful change over the course of the study. Assessment was based on AHI, severity and frequency of oxygen desaturations and sleep quality.
Outcome measures
| Measure |
Aldurazyme (rhIDU) 100 U/kg Every Week
n=15 Participants
Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks - labeled dose.
|
Aldurazyme (rhIDU) 100-200 U/kg Every Week
After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient's urinary glycosaminoglycan (uGAG) levels were \>200µg/mg creatinine at Week 22.
|
|---|---|---|
|
Expert Global Assessment of Sleep Study Results at Week 52 Compared With Baseline
Moderate Improvement
|
3 participants
|
—
|
|
Expert Global Assessment of Sleep Study Results at Week 52 Compared With Baseline
Mild Improvement
|
1 participants
|
—
|
|
Expert Global Assessment of Sleep Study Results at Week 52 Compared With Baseline
Slight Worsening
|
3 participants
|
—
|
|
Expert Global Assessment of Sleep Study Results at Week 52 Compared With Baseline
Moderate Worsening
|
1 participants
|
—
|
|
Expert Global Assessment of Sleep Study Results at Week 52 Compared With Baseline
Marked Worsening
|
1 participants
|
—
|
|
Expert Global Assessment of Sleep Study Results at Week 52 Compared With Baseline
Marked Improvement
|
1 participants
|
—
|
|
Expert Global Assessment of Sleep Study Results at Week 52 Compared With Baseline
No change
|
5 participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 52 weeksPopulation: The analysis was intent-to-treat.
Change in LVM Z-scores as measured by echocardiography from Baseline to Week 52. Z-score=number of standard deviations from mean. Z-scores greater than +2 and less than -2 are abnormal. A greater decrease in abnormally high z-score indicates a greater response.
Outcome measures
| Measure |
Aldurazyme (rhIDU) 100 U/kg Every Week
n=17 Participants
Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks - labeled dose.
|
Aldurazyme (rhIDU) 100-200 U/kg Every Week
After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient's urinary glycosaminoglycan (uGAG) levels were \>200µg/mg creatinine at Week 22.
|
|---|---|---|
|
Change From Baseline to Week 52 in Left Ventricular Mass (LVM) Z-Score
|
-0.9 Units on a scale
Standard Deviation 1.58
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 52 weeksPopulation: The analysis was intent-to-treat.
Change in Z-scores for standing height/lying-length-for-age from Baseline to Week 52. Z-score=number of standard deviations from mean. Z-scores greater than +2 and less than -2 are abnormal. A greater decrease in abnormally high z-score indicates a greater response.
Outcome measures
| Measure |
Aldurazyme (rhIDU) 100 U/kg Every Week
n=17 Participants
Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks - labeled dose.
|
Aldurazyme (rhIDU) 100-200 U/kg Every Week
After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient's urinary glycosaminoglycan (uGAG) levels were \>200µg/mg creatinine at Week 22.
|
|---|---|---|
|
Change From Baseline to Week 52 in Height
|
-0.5 Units on a scale
Standard Deviation 0.93
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 52 weeksPopulation: The analysis was intent-to-treat.
The Investigator's impression of the patient's overall clinical status at Week 52 compared with Baseline.
Outcome measures
| Measure |
Aldurazyme (rhIDU) 100 U/kg Every Week
n=18 Participants
Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks - labeled dose.
|
Aldurazyme (rhIDU) 100-200 U/kg Every Week
After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient's urinary glycosaminoglycan (uGAG) levels were \>200µg/mg creatinine at Week 22.
|
|---|---|---|
|
Investigator's Clinical Assessment at Week 52 Compared With Baseline
Marked Improvement
|
0 participants
|
—
|
|
Investigator's Clinical Assessment at Week 52 Compared With Baseline
No Change
|
1 participants
|
—
|
|
Investigator's Clinical Assessment at Week 52 Compared With Baseline
Slight Worsening
|
0 participants
|
—
|
|
Investigator's Clinical Assessment at Week 52 Compared With Baseline
Moderate Worsening
|
0 participants
|
—
|
|
Investigator's Clinical Assessment at Week 52 Compared With Baseline
Marked Worsening
|
0 participants
|
—
|
|
Investigator's Clinical Assessment at Week 52 Compared With Baseline
Moderate Improvement
|
6 participants
|
—
|
|
Investigator's Clinical Assessment at Week 52 Compared With Baseline
Mild Improvement
|
11 participants
|
—
|
Adverse Events
Aldurazyme ***Check Title***
Serious events: 15 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aldurazyme ***Check Title***
n=20 participants at risk
Aldurazyme \*\*\*check title\*\*\*
|
|---|---|
|
Cardiac disorders
Cardiac failure
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Cardiac disorders
Cyanosis
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Cardiac disorders
Tachycardia
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Congenital, familial and genetic disorders
Hip dysplasia
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Dental caries
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Inguinal hernia
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Umbilical hernia
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Catheter related complication
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Pyrexia
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Ear infection
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Gastroenteritis
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Lower respiratory tract infection
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Otitis media
|
20.0%
4/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Pharyngitis
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Post procedural infection
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory distress
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Blood pressure increased
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Medical observation
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Oxygen saturation decreased
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Cerebral haemorrhage
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Convulsion
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal disorder
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Surgical and medical procedures
Adenotonsillectomy
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Surgical and medical procedures
Catheterisation venous
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Surgical and medical procedures
Central venous catheterisation
|
15.0%
3/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Surgical and medical procedures
Ear tube insertion
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Surgical and medical procedures
Ear tube removal
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Vascular disorders
Poor venous access
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
Other adverse events
| Measure |
Aldurazyme ***Check Title***
n=20 participants at risk
Aldurazyme \*\*\*check title\*\*\*
|
|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Cardiac disorders
Angina pectoris
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Cardiac disorders
Aortic valve disease
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Cardiac disorders
Aortic valve incompetence
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Cardiac disorders
Mitral valve incompetence
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Cardiac disorders
Tachycardia
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Ear and labyrinth disorders
Ear congestion
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Ear and labyrinth disorders
Ear pain
|
20.0%
4/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Ear and labyrinth disorders
Ear pruritus
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Ear and labyrinth disorders
Otorrhoea
|
50.0%
10/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
Conjunctivitis
|
15.0%
3/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
Eye discharge
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
Lacrimation increased
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
Ocular hypertension
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
Strabismus
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Diarrhoea
|
85.0%
17/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Faecal incontinence
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Inguinal hernia
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Lip haematoma
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Retching
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Teething
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Toothache
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Umbilical hernia
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Vomiting
|
70.0%
14/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Adverse drug reaction
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Catheter related complication
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Catheter site discharge
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Catheter site swelling
|
20.0%
4/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Chills
|
20.0%
4/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Crepitations
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Cyst
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Facial pain
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Fatigue
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Feeling hot
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Gait disturbance
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Inflammation
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Oedema peripheral
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Pain
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Pyrexia
|
100.0%
20/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Abscess
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Bacterial disease carrier
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Bacterial infection
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Bronchitis
|
35.0%
7/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Candida nappy rash
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Conjunctivitis infective
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Ear infection
|
25.0%
5/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Eye infection
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Fungal infection
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Gastroenteritis
|
30.0%
6/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Gingival abscess
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Lower respiratory tract infection
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Nasopharyngitis
|
40.0%
8/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Oral candidiasis
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Oral herpes
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Otitis externa
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Otitis media
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Paronychia
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Pharyngitis
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Rhinitis
|
55.0%
11/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Rubella
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.0%
3/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Varicella
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Ear injury
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Face injury
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Fall
|
15.0%
3/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Gingival injury
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Head injury
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Laceration
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Wound
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Bacterial culture positive
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Blood iron decreased
|
15.0%
3/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Blood pressure decreased
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Blood pressure increased
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Body temperature increased
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Breath sounds abnormal
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Cardiac murmur
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Haemoglobin decreased
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Heart rate increased
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Lymph node palpable
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Oxygen saturation decreased
|
15.0%
3/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Platelet count increased
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Urine analysis abnormal
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
White blood cell count increased
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Metabolism and nutrition disorders
Fluid intake reduced
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.0%
3/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Head discomfort
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Headache
|
15.0%
3/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Hemiparesis
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Hyperreflexia
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Lethargy
|
15.0%
3/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
Listless
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
Restlessness
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
Self-induced vomiting
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Renal and urinary disorders
Dysuria
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Renal and urinary disorders
Urinary incontinence
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Reproductive system and breast disorders
Pruritus genital
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
85.0%
17/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
15.0%
3/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
60.0%
12/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
10/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
10.0%
2/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Vascular disorders
Haematoma
|
15.0%
3/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Vascular disorders
Hypertension
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Vascular disorders
Pallor
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Vascular disorders
Vein disorder
|
5.0%
1/20
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
Additional Information
Genzyme Medical Information
Genzyme Corporation
Phone: 800-745-4447
Results disclosure agreements
- Principal investigator is a sponsor employee In multi-site studies, PI can publish after Genzyme publishes or 18 months after study completion. PI gives Genzyme a draft 60 days before publication. Genzyme can ask that confidential information be removed, and can defer publication another 60 days upon notifying PI that it will file a patent application on inventions contained in the draft.
- Publication restrictions are in place
Restriction type: OTHER