Trial Outcomes & Findings for An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment (NCT NCT01506141)
NCT ID: NCT01506141
Last Updated: 2025-08-06
Results Overview
An adverse event (AE) is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, and/or laboratory changes occurring in any phase of a clinical trial, and whether or not considered study drug-related. TEAEs were defined as all AEs occurring on or after the first IDDD surgery date or first dose (whichever is earlier) for the participant (whether it is in this extension study or in HGT HIT-045 \[NCT00920647\]) and before the end of the study (EOS) visit (+30 days). For Idursulfase-IT 1 mg+10 mg arm the summary presented includes only the TEAEs that occurred while the participants were assigned to 10 mg.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
From start of study drug administration up to follow-up (up to 165 months)
Results posted on
2025-08-06
Participant Flow
Participants took part in the study at various investigative sites in the United States (US) and the United Kingdom (UK) from 01 August 2010 to 30 April 2024.
15 participants who completed the Study HGT-HIT-045 (NCT00920647) received idursulfase-IT in conjunction with Elaprase therapy. Participants who received idursulfase-IT treatment in study HGT-HIT-045, initiated treatment at the same dose level and were analyzed as per the reference timepoints of HGT-HIT-045 for some evaluations. For others, the reference timepoints after enrollment to this extension study were considered.
Participant milestones
| Measure |
Idursulfase-IT 10 mg
Participants received 10 mg idursulfase-IT initially intrathecally via intrathecal drug delivery device (IDDD) or lumbar puncture (LP) once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
5
|
|
Overall Study
Transferred From 1 mg Arm
|
4
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
Idursulfase-IT 10 mg
Participants received 10 mg idursulfase-IT initially intrathecally via intrathecal drug delivery device (IDDD) or lumbar puncture (LP) once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Participation Terminated by Investigator
|
1
|
1
|
|
Overall Study
Site Terminated by Sponsor
|
2
|
0
|
|
Overall Study
Reason Not Specified
|
4
|
2
|
Baseline Characteristics
An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment
Baseline characteristics by cohort
| Measure |
Idursulfase-IT 1 mg
n=4 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
n=6 Participants
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 157.2 months.
|
Idursulfase-IT 30 mg
n=5 Participants
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
5.61 years
STANDARD_DEVIATION 1.799 • n=99 Participants
|
5.68 years
STANDARD_DEVIATION 2.501 • n=107 Participants
|
7.94 years
STANDARD_DEVIATION 2.706 • n=206 Participants
|
6.41 years
STANDARD_DEVIATION 2.502 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to follow-up (up to 165 months)Population: Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study.
An adverse event (AE) is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, and/or laboratory changes occurring in any phase of a clinical trial, and whether or not considered study drug-related. TEAEs were defined as all AEs occurring on or after the first IDDD surgery date or first dose (whichever is earlier) for the participant (whether it is in this extension study or in HGT HIT-045 \[NCT00920647\]) and before the end of the study (EOS) visit (+30 days). For Idursulfase-IT 1 mg+10 mg arm the summary presented includes only the TEAEs that occurred while the participants were assigned to 10 mg.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=4 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
n=10 Participants
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
n=5 Participants
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
4 Participants
|
10 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to follow-up (up to 165 months)Population: Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study.
Number of participants with clinically significant changes in laboratory parameters (chemistry, hematology, urinalysis and CSF values) were collected.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=4 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
n=10 Participants
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
n=5 Participants
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes or Apparent Difference Across Treatment Groups in Laboratory Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to follow-up (up to 165 months)Population: Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study.
Number of participants with clinically significant changes in 12-lead Electrocardiogram (ECG) findings (heart rate, PR interval, QRS interval, QT interval and the corrected QT interval) were collected.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=4 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
n=10 Participants
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
n=5 Participants
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes or Apparent Difference Across Treatment Groups in 12-lead Electrocardiogram (ECG) Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 163Population: Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. Overall number analyzed are the number of participants who had data at Baseline. Number analyzed indicates the number of participants with data available for analyses at specified time points.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=4 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
n=6 Participants
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
n=5 Participants
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
CSF Chemistries: Change From Baseline in CSF Total Cell Count
Baseline
|
1.0 10^6 cells/Liter (L)
Standard Deviation 0.00
|
1.0 10^6 cells/Liter (L)
Standard Deviation 0.00
|
1.0 10^6 cells/Liter (L)
Standard Deviation 0.00
|
|
CSF Chemistries: Change From Baseline in CSF Total Cell Count
Change From Baseline in CSF Total Cell Count at Month 163
|
—
|
7.3 10^6 cells/Liter (L)
Standard Deviation 11.85
|
—
|
PRIMARY outcome
Timeframe: Baseline, Month 163Population: Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. Overall number analyzed are the number of participants who had data at Baseline. Number analyzed indicates the number of participants with data available for analyses at specified time points.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=4 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
n=6 Participants
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
n=5 Participants
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
CSF Chemistries: Change From Baseline in CSF Glucose
Baseline
|
2.950 millimoles per liter (mmol/L)
Standard Deviation 0.265
|
2.850 millimoles per liter (mmol/L)
Standard Deviation 0.217
|
3.000 millimoles per liter (mmol/L)
Standard Deviation 0.200
|
|
CSF Chemistries: Change From Baseline in CSF Glucose
Change from Baseline in CSF Glucose at Month 163
|
—
|
0.523 millimoles per liter (mmol/L)
Standard Deviation 0.436
|
—
|
PRIMARY outcome
Timeframe: Baseline, Month 163Population: Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. Overall number analyzed are the number of participants who had data at Baseline. Number analyzed indicates the number of participants with data available for analyses at specified time points.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=4 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
n=6 Participants
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
n=5 Participants
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
CSF Chemistries: Change From Baseline in CSF Protein
Baseline
|
0.400 grams per liter (g/L)
Standard Deviation 0.194
|
0.282 grams per liter (g/L)
Standard Deviation 0.144
|
0.530 grams per liter (g/L)
Standard Deviation 0.368
|
|
CSF Chemistries: Change From Baseline in CSF Protein
Change from Baseline in CSF Protein at Month 163
|
—
|
0.493 grams per liter (g/L)
Standard Deviation 0.229
|
—
|
PRIMARY outcome
Timeframe: From start of study drug administration up to follow-up (up to 165 months)Population: Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=4 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
n=10 Participants
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
n=5 Participants
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
Number of Participants With Anti-idursulfase Antibodies in CSF
Post-Baseline
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Anti-idursulfase Antibodies in CSF
At Baseline
|
3 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to follow-up (up to 165 months)Population: Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=4 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
n=10 Participants
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
n=5 Participants
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
Number of Participants With Anti-idursulfase Antibodies in Serum
At Baseline
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Anti-idursulfase Antibodies in Serum
Post-Baseline
|
3 Participants
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 15 minutes prior to IT injection, at 1,2,3,4,6,8,12,24,30,36 hours (±1 hour) following IT injection on Day 2 of Weeks 3,23, for 1 mg arm group and on Day 2 of Weeks 3,23, Months 19,31,43,55,67,79 for 10 and 30 mg arm groupsPopulation: PK population included all participants who received study drug \& participated in the scheduled pharmacokinetic studies,\& for whom at least 1 post-dose PK blood sample was collected. Overall number analyzed indicates number of participants with data available for analyses. Number analyzed indicates number of participants with data available for analyses at specified time points.
Area under the curve extrapolated to infinity, calculated using the observed value of the last non-zero concentration (AUC0-infinity) of idursulfase was assessed. Participants in 1 mg arm group were assessed for Pharmacokinetic (PK) analysis in the HGT-HIT-045 study.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=3 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
n=6 Participants
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
n=5 Participants
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
Area Under the Curve Extrapolated to Infinity (AUC0-infinity) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Week 3: Day 2
|
NA hours*nanograms per milliliter(h*ng/mL)
Standard Deviation NA
Mean and Standard Deviation (SD) were not estimable as values were below lower limit of quantification (LLOQ).
|
—
|
—
|
|
Area Under the Curve Extrapolated to Infinity (AUC0-infinity) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Week 23: Day 2
|
1574.37 hours*nanograms per milliliter(h*ng/mL)
Standard Deviation NA
SD was not estimable for a single participant.
|
1765 hours*nanograms per milliliter(h*ng/mL)
Standard Deviation NA
SD was not estimable for a single participant.
|
—
|
|
Area Under the Curve Extrapolated to Infinity (AUC0-infinity) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 19: Day 2
|
—
|
2869 hours*nanograms per milliliter(h*ng/mL)
Standard Deviation 563.1
|
5179 hours*nanograms per milliliter(h*ng/mL)
Standard Deviation 2579.8
|
|
Area Under the Curve Extrapolated to Infinity (AUC0-infinity) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 31: Day 2
|
—
|
2649 hours*nanograms per milliliter(h*ng/mL)
Standard Deviation 1334.8
|
4766 hours*nanograms per milliliter(h*ng/mL)
Standard Deviation NA
SD was not estimable for a single participant.
|
|
Area Under the Curve Extrapolated to Infinity (AUC0-infinity) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 43
|
—
|
2324 hours*nanograms per milliliter(h*ng/mL)
Standard Deviation 203.0
|
4395 hours*nanograms per milliliter(h*ng/mL)
Standard Deviation 733.1
|
|
Area Under the Curve Extrapolated to Infinity (AUC0-infinity) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 55
|
—
|
1636 hours*nanograms per milliliter(h*ng/mL)
Standard Deviation 351.4
|
2445 hours*nanograms per milliliter(h*ng/mL)
Standard Deviation 1770.8
|
|
Area Under the Curve Extrapolated to Infinity (AUC0-infinity) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 67
|
—
|
1649 hours*nanograms per milliliter(h*ng/mL)
Standard Deviation 167.4
|
3270 hours*nanograms per milliliter(h*ng/mL)
Standard Deviation 801.6
|
|
Area Under the Curve Extrapolated to Infinity (AUC0-infinity) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 79
|
—
|
1865 hours*nanograms per milliliter(h*ng/mL)
Standard Deviation 775.2
|
—
|
SECONDARY outcome
Timeframe: 15 minutes prior to IT injection, at 1,2,3,4,6,8,12,24,30,36 hours (±1 hour) following IT injection on Day 2 of Weeks 3,23, for 1 mg arm group and on Day 2 of Weeks 3,23, Months 19,31,43,55,67,79 for 10 and 30 mg arm groupsPopulation: PK population included all participants who received study drug and participated in the scheduled pharmacokinetic studies, and for whom at least 1 post-dose PK blood sample was collected. Overall number analyzed indicates the number of participants with data available for analyses. Number analyzed indicates the number of participants with data available for analyses at specified time points.
Participants in 1 mg arm group were assessed for PK analysis in the HGT-HIT-045 study.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=3 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
n=7 Participants
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
n=5 Participants
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
Area Under the Curve From the Time of Dosing to the Last Measureable Concentration (AUC0-t) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Week 3: Day 2
|
NA h*ng/mL
Standard Deviation NA
Mean and SD were not estimable as values were below LLOQ.
|
1214 h*ng/mL
Standard Deviation NA
SD was not estimable for a single participant.
|
3746 h*ng/mL
Standard Deviation NA
SD was not estimable for a single participant.
|
|
Area Under the Curve From the Time of Dosing to the Last Measureable Concentration (AUC0-t) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 19: Day 2
|
—
|
1633 h*ng/mL
Standard Deviation 976.6
|
3525 h*ng/mL
Standard Deviation 835.5
|
|
Area Under the Curve From the Time of Dosing to the Last Measureable Concentration (AUC0-t) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 43
|
—
|
1944 h*ng/mL
Standard Deviation 295.8
|
3141 h*ng/mL
Standard Deviation 979.7
|
|
Area Under the Curve From the Time of Dosing to the Last Measureable Concentration (AUC0-t) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 55
|
—
|
1356 h*ng/mL
Standard Deviation 235.3
|
1466 h*ng/mL
Standard Deviation 1511.8
|
|
Area Under the Curve From the Time of Dosing to the Last Measureable Concentration (AUC0-t) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 67
|
—
|
1247 h*ng/mL
Standard Deviation 204.0
|
2415 h*ng/mL
Standard Deviation 394.8
|
|
Area Under the Curve From the Time of Dosing to the Last Measureable Concentration (AUC0-t) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Week 23: Day 2
|
524.68 h*ng/mL
Standard Deviation NA
SD was not estimable for a single participant.
|
1047 h*ng/mL
Standard Deviation NA
SD was not estimable for a single participant.
|
4855 h*ng/mL
Standard Deviation NA
SD was not estimable for a single participant.
|
|
Area Under the Curve From the Time of Dosing to the Last Measureable Concentration (AUC0-t) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 31: Day 2
|
—
|
2031 h*ng/mL
Standard Deviation 1081.9
|
3586 h*ng/mL
Standard Deviation 1056.9
|
|
Area Under the Curve From the Time of Dosing to the Last Measureable Concentration (AUC0-t) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 79
|
—
|
1500 h*ng/mL
Standard Deviation 347.1
|
—
|
SECONDARY outcome
Timeframe: 15 minutes prior to IT injection, at 1,2,3,4,6,8,12,24,30,36 hours (±1 hour) following IT injection on Day 2 of Weeks 3,23, for 1 mg arm group and on Day 2 of Weeks 3,23, Months 19,31,43,55,67,79 for 10 and 30 mg arm groupsPopulation: PK population included all participants who received study drug and participated in the scheduled pharmacokinetic studies, and for whom at least 1 post-dose PK blood sample was collected. Overall number analyzed indicates the number of participants with data available for analyses. Number analyzed indicates the number of participants with data available for analyses at specified time points.
Participants in 1 mg arm group were assessed for PK analysis in the HGT-HIT-045 study.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=3 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
n=7 Participants
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
n=5 Participants
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Week 3: Day 2
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Mean and SD were not estimable as values were below LLOQ.
|
43.95 nanograms per milliliter (ng/mL)
Standard Deviation NA
SD was not estimable for a single participant.
|
146.75 nanograms per milliliter (ng/mL)
Standard Deviation NA
SD was not estimable for a single participant.
|
|
Maximum Observed Concentration (Cmax) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Week 23: Day 2
|
19 nanograms per milliliter (ng/mL)
Standard Deviation NA
SD was not estimable for a single participant.
|
36.10 nanograms per milliliter (ng/mL)
Standard Deviation NA
SD was not estimable for a single participant.
|
173.40 nanograms per milliliter (ng/mL)
Standard Deviation NA
SD was not estimable for a single participant.
|
|
Maximum Observed Concentration (Cmax) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 55
|
—
|
61.50 nanograms per milliliter (ng/mL)
Standard Deviation 19.330
|
93.43 nanograms per milliliter (ng/mL)
Standard Deviation 61.406
|
|
Maximum Observed Concentration (Cmax) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 67
|
—
|
56.73 nanograms per milliliter (ng/mL)
Standard Deviation 12.690
|
99.20 nanograms per milliliter (ng/mL)
Standard Deviation 19.762
|
|
Maximum Observed Concentration (Cmax) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 19: Day 2
|
—
|
76.39 nanograms per milliliter (ng/mL)
Standard Deviation 51.386
|
156.80 nanograms per milliliter (ng/mL)
Standard Deviation 33.054
|
|
Maximum Observed Concentration (Cmax) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 31: Day 2
|
—
|
143.52 nanograms per milliliter (ng/mL)
Standard Deviation 122.774
|
175.20 nanograms per milliliter (ng/mL)
Standard Deviation 70.083
|
|
Maximum Observed Concentration (Cmax) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 43
|
—
|
90.57 nanograms per milliliter (ng/mL)
Standard Deviation 28.720
|
144.35 nanograms per milliliter (ng/mL)
Standard Deviation 44.434
|
|
Maximum Observed Concentration (Cmax) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 79
|
—
|
64.08 nanograms per milliliter (ng/mL)
Standard Deviation 7.835
|
—
|
SECONDARY outcome
Timeframe: 15 minutes prior to IT injection, at 1,2,3,4,6,8,12,24,30,36 hours (±1 hour) following IT injection on Day 2 of Weeks 3,23, for 1 mg arm group and on Day 2 of Weeks 3,23, Months 19,31,43,55,67,79 for 10 and 30 mg arm groupsPopulation: PK population included all participants who received study drug and participated in the scheduled pharmacokinetic studies, and for whom at least 1 post-dose PK blood sample was collected. Overall number analyzed indicates the number of participants with data available for analyses. Number analyzed indicates the number of participants with data available for analyses at specified time points.
Participants in 1 mg arm group were assessed for PK analysis in the HGT-HIT-045 study.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=3 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
n=7 Participants
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
n=5 Participants
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
Time of Maximum Observed Concentration (Tmax) of Idursulfase Administered in as Intrathecal and in Conjunction With Elaprase
Month 55
|
—
|
12.00 hours
Interval 6.0 to 12.0
|
7.97 hours
Interval 2.0 to 8.0
|
|
Time of Maximum Observed Concentration (Tmax) of Idursulfase Administered in as Intrathecal and in Conjunction With Elaprase
Month 67
|
—
|
12.00 hours
Interval 6.0 to 12.0
|
12.00 hours
Interval 6.0 to 30.0
|
|
Time of Maximum Observed Concentration (Tmax) of Idursulfase Administered in as Intrathecal and in Conjunction With Elaprase
Week 3: Day 2
|
NA hours
Median and Full range were not estimable as values were below LLOQ.
|
24.03 hours
Full range was not estimable for a single participant.
|
36.07 hours
Full range was not estimable for a single participant.
|
|
Time of Maximum Observed Concentration (Tmax) of Idursulfase Administered in as Intrathecal and in Conjunction With Elaprase
Week 23: Day 2
|
8.03 hours
Full range was not estimable for a single participant.
|
12.00 hours
Full range was not estimable for a single participant.
|
12.00 hours
Full range was not estimable for a single participant.
|
|
Time of Maximum Observed Concentration (Tmax) of Idursulfase Administered in as Intrathecal and in Conjunction With Elaprase
Month 19: Day 2
|
—
|
12.00 hours
Interval 6.0 to 36.2
|
24.00 hours
Interval 2.0 to 30.0
|
|
Time of Maximum Observed Concentration (Tmax) of Idursulfase Administered in as Intrathecal and in Conjunction With Elaprase
Month 31: Day 2
|
—
|
9.99 hours
Interval 1.12 to 12.0
|
17.98 hours
Interval 6.0 to 30.1
|
|
Time of Maximum Observed Concentration (Tmax) of Idursulfase Administered in as Intrathecal and in Conjunction With Elaprase
Month 43
|
—
|
12.00 hours
Interval 8.0 to 12.0
|
10.02 hours
Interval 6.03 to 12.0
|
|
Time of Maximum Observed Concentration (Tmax) of Idursulfase Administered in as Intrathecal and in Conjunction With Elaprase
Month 79
|
—
|
10.00 hours
Interval 8.0 to 12.0
|
—
|
SECONDARY outcome
Timeframe: 15 minutes prior to IT injection, at 1,2,3,4,6,8,12,24,30,36 hours (±1 hour) following IT injection on Day 2 of Weeks 3,23, for 1 mg arm group and on Day 2 of Weeks 3,23, Months 19,31,43,55,67,79 for 10 and 30 mg arm groupsPopulation: PK population included all participants who received study drug and participated in the scheduled pharmacokinetic studies, and for whom at least 1 post-dose PK blood sample was collected. Overall number analyzed indicates the number of participants with data available for analyses. Number analyzed indicates the number of participants with data available for analyses at specified time points.
Participants in 1 mg arm group were assessed for PK analysis in the HGT-HIT-045 study.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=3 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
n=6 Participants
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
n=5 Participants
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed (Cl/F) of Idursulfase-IT Administered as Intrathecal and in Conjunction With Elaprase
Week 3: Day 2
|
NA liters per hour (L/h)
Standard Deviation NA
Mean and SD were not estimable as values were below LLOQ.
|
—
|
—
|
|
Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed (Cl/F) of Idursulfase-IT Administered as Intrathecal and in Conjunction With Elaprase
Week 23: Day 2
|
NA liters per hour (L/h)
Standard Deviation NA
Mean and SD were not estimable as values were below LLOQ.
|
5.67 liters per hour (L/h)
Standard Deviation NA
SD was not estimable for a single participant.
|
—
|
|
Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed (Cl/F) of Idursulfase-IT Administered as Intrathecal and in Conjunction With Elaprase
Month 19: Day 2
|
—
|
3.59 liters per hour (L/h)
Standard Deviation 0.763
|
6.61 liters per hour (L/h)
Standard Deviation 3.295
|
|
Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed (Cl/F) of Idursulfase-IT Administered as Intrathecal and in Conjunction With Elaprase
Month 31: Day 2
|
—
|
4.80 liters per hour (L/h)
Standard Deviation 2.667
|
6.29 liters per hour (L/h)
Standard Deviation NA
SD was not estimable for a single participant.
|
|
Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed (Cl/F) of Idursulfase-IT Administered as Intrathecal and in Conjunction With Elaprase
Month 43
|
—
|
4.33 liters per hour (L/h)
Standard Deviation 0.377
|
6.92 liters per hour (L/h)
Standard Deviation 1.154
|
|
Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed (Cl/F) of Idursulfase-IT Administered as Intrathecal and in Conjunction With Elaprase
Month 55
|
—
|
6.33 liters per hour (L/h)
Standard Deviation 1.548
|
8.25 liters per hour (L/h)
Standard Deviation 0.191
|
|
Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed (Cl/F) of Idursulfase-IT Administered as Intrathecal and in Conjunction With Elaprase
Month 67
|
—
|
6.10 liters per hour (L/h)
Standard Deviation 0.619
|
9.46 liters per hour (L/h)
Standard Deviation 2.319
|
|
Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed (Cl/F) of Idursulfase-IT Administered as Intrathecal and in Conjunction With Elaprase
Month 79
|
—
|
5.96 liters per hour (L/h)
Standard Deviation 2.207
|
—
|
SECONDARY outcome
Timeframe: 15 minutes prior to IT injection, at 1,2,3,4,6,8,12,24,30,36 hours (±1 hour) following IT injection on Day 2 of Weeks 3,23, for 1 mg arm group and on Day 2 of Weeks 3,23, Months 19,31,43,55,67,79 for 10 and 30 mg arm groupsPopulation: PK population included all participants who received study drug and participated in the scheduled pharmacokinetic studies, and for whom at least 1 post-dose PK blood sample was collected. Overall number analyzed indicates the number of participants with data available for analyses. Number analyzed indicates the number of participants with data available for analyses at specified time points.
Participants in 1 mg arm group were assessed for PK analysis in the HGT-HIT-045 study.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=3 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
n=6 Participants
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
n=5 Participants
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration Divided by the Fraction of Dose Absorbed (Vz/F) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 55
|
—
|
130.84 liters
Standard Deviation 15.624
|
127.77 liters
Standard Deviation 11.009
|
|
Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration Divided by the Fraction of Dose Absorbed (Vz/F) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 67
|
—
|
115.31 liters
Standard Deviation 29.260
|
206.92 liters
Standard Deviation 11.864
|
|
Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration Divided by the Fraction of Dose Absorbed (Vz/F) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Week 3: Day 2
|
NA liters
Standard Deviation NA
Mean and SD were not estimable as values were below LLOQ.
|
—
|
—
|
|
Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration Divided by the Fraction of Dose Absorbed (Vz/F) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Week 23: Day 2
|
52.831 liters
Standard Deviation NA
SD was not estimable for a single participant.
|
183.31 liters
Standard Deviation NA
SD was not estimable for a single participant.
|
—
|
|
Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration Divided by the Fraction of Dose Absorbed (Vz/F) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 19: Day 2
|
—
|
94.18 liters
Standard Deviation 21.961
|
152.82 liters
Standard Deviation 45.153
|
|
Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration Divided by the Fraction of Dose Absorbed (Vz/F) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 31: Day 2
|
—
|
116.91 liters
Standard Deviation 84.881
|
128.63 liters
Standard Deviation NA
SD was not estimable for a single participant.
|
|
Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration Divided by the Fraction of Dose Absorbed (Vz/F) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 43
|
—
|
68.06 liters
Standard Deviation 21.783
|
104.93 liters
Standard Deviation 44.848
|
|
Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration Divided by the Fraction of Dose Absorbed (Vz/F) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 79
|
—
|
79.22 liters
Standard Deviation 8.364
|
—
|
SECONDARY outcome
Timeframe: 15 minutes prior to IT injection, at 1,2,3,4,6,8,12,24,30,36 hours (±1 hour) following IT injection on Day 2 of Weeks 3,23, for 1 mg arm group and on Day 2 of Weeks 3,23, Months 19,31,43,55,67,79 for 10 and 30 mg arm groupsPopulation: PK population included all participants who received study drug and participated in the scheduled pharmacokinetic studies, and for whom at least 1 post-dose PK blood sample was collected. Overall number analyzed indicates the number of participants with data available for analyses. Number analyzed indicates the number of participants with data available for analyses at specified time points.
Participants in 1 mg arm group were assessed for PK analysis in the HGT-HIT-045 study.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=3 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
n=6 Participants
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
n=5 Participants
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
First Order Rate Constant (Lambda z) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 79
|
—
|
0.0772 per hour (/h)
Standard Deviation 0.03550
|
—
|
|
First Order Rate Constant (Lambda z) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Week 3: Day 2
|
NA per hour (/h)
Standard Deviation NA
Mean and SD were not estimable as values were below LLOQ.
|
—
|
—
|
|
First Order Rate Constant (Lambda z) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Week 23: Day 2
|
NA per hour (/h)
Standard Deviation NA
Mean and SD were not estimable as values were below LLOQ.
|
0.0309 per hour (/h)
Standard Deviation NA
SD was not estimable for a single participant.
|
—
|
|
First Order Rate Constant (Lambda z) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 19: Day 2
|
—
|
0.0383 per hour (/h)
Standard Deviation 0.00260
|
0.0419 per hour (/h)
Standard Deviation 0.00917
|
|
First Order Rate Constant (Lambda z) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 31: Day 2
|
—
|
0.0487 per hour (/h)
Standard Deviation 0.01996
|
0.0489 per hour (/h)
Standard Deviation NA
SD was not estimable for a single participant.
|
|
First Order Rate Constant (Lambda z) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 43
|
—
|
0.0677 per hour (/h)
Standard Deviation 0.01829
|
0.0700 per hour (/h)
Standard Deviation 0.01892
|
|
First Order Rate Constant (Lambda z) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 55
|
—
|
0.0486 per hour (/h)
Standard Deviation 0.01126
|
0.0649 per hour (/h)
Standard Deviation 0.00708
|
|
First Order Rate Constant (Lambda z) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 67
|
—
|
0.0539 per hour (/h)
Standard Deviation 0.00831
|
0.0455 per hour (/h)
Standard Deviation 0.00860
|
SECONDARY outcome
Timeframe: 15 minutes prior to IT injection, at 1,2,3,4,6,8,12,24,30,36 hours (±1 hour) following IT injection on Day 2 of Weeks 3,23, for 1 mg arm group and on Day 2 of Weeks 3,23, Months 19,31,43,55,67,79 for 10 and 30 mg arm groupsPopulation: PK population included all participants who received study drug and participated in the scheduled pharmacokinetic studies, and for whom at least 1 post-dose PK blood sample was collected. Overall number analyzed indicates the number of participants with data available for analyses. Number analyzed indicates the number of participants with data available for analyses at specified time points.
Participants in 1 mg arm group were assessed for PK analysis in the HGT-HIT-045 study. T1/2 is calculated by dividing 0.693 by Lambda z. Here, 0.693 is the natural logarithm of 2 and Lambda z is the first order rate constant.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=3 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
n=6 Participants
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
n=5 Participants
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
Terminal Half-life (t1/2) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Week 3: Day 2
|
NA hours
Median and Full range were not estimable as values were below LLOQ.
|
—
|
—
|
|
Terminal Half-life (t1/2) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Week 23: Day 2
|
NA hours
T½ was not estimable due to non-availability of the Lambda z values.
|
22.43 hours
Full range was not estimable for a single participant.
|
—
|
|
Terminal Half-life (t1/2) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 67
|
—
|
13.01 hours
Interval 11.6 to 14.4
|
15.52 hours
Interval 13.4 to 17.6
|
|
Terminal Half-life (t1/2) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 79
|
—
|
9.68 hours
Interval 6.02 to 15.4
|
—
|
|
Terminal Half-life (t1/2) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 19: Day 2
|
—
|
18.20 hours
Interval 16.9 to 19.4
|
16.94 hours
Interval 14.3 to 19.6
|
|
Terminal Half-life (t1/2) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 31: Day 2
|
—
|
15.57 hours
Interval 8.35 to 29.8
|
14.16 hours
Full range was not estimable for a single participant.
|
|
Terminal Half-life (t1/2) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 43
|
—
|
10.28 hours
Interval 8.21 to 14.7
|
10.28 hours
Interval 8.31 to 12.2
|
|
Terminal Half-life (t1/2) of Idursulfase Administered as Intrathecal and in Conjunction With Elaprase
Month 55
|
—
|
14.21 hours
Interval 11.6 to 18.6
|
10.75 hours
Interval 9.92 to 11.6
|
SECONDARY outcome
Timeframe: 15 minutes prior to IV infusion, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 9, 11, and 24 hours during/after the IV infusion on Days 3-7 of Weeks 3 and 23Population: Participants who received only Elaprase in HGT-HIT-045 and had evaluable samples were analyzed for this outcome measure. Number analyzed indicates the number of participants with data available for analyses at the specified time point.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=2 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
Total Body Clearance (CL) of Elaprase
Week 3: Day 3-7
|
1.94 liters per hour (L/h)
Standard Deviation 1.677
|
—
|
—
|
|
Total Body Clearance (CL) of Elaprase
Week 23: Day 3-7
|
3.47 liters per hour (L/h)
Standard Deviation NA
SD was not estimable for a single participant.
|
—
|
—
|
SECONDARY outcome
Timeframe: 15 minutes prior to IV infusion and at multiple timepoint (0.5, 1, 1.5, 2, 2.5, and 3 hours during the infusion; and at 3.5, 4, 5, 6, 7, 9, 11, and 24 hours) following IV infusion on Days 3-7 of Weeks 3 and 23Population: Participants who received only Elaprase in HGT-HIT-045 and had evaluable samples were analyzed for this outcome measure. Number analyzed indicates the number of participants with data available for analyses at the specified time point.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=2 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
Observed Steady-state Volume of Distribution (Vss) of Elaprase
Week 3: Day 3-7
|
9.40 liters
Standard Deviation 3.464
|
—
|
—
|
|
Observed Steady-state Volume of Distribution (Vss) of Elaprase
Week 23: Day 3-7
|
13.19 liters
Standard Deviation NA
SD was not estimable for a single participant.
|
—
|
—
|
SECONDARY outcome
Timeframe: 15 minutes prior to IV infusion and at multiple timepoints (0.5, 1, 1.5, 2, 2.5, and 3 hours during the infusion; and at 3.5, 4, 5, 6, 7, 9, 11, and 24 hours) following IV infusion on Days 3-7 of Weeks 3 and 23Population: Participants who received only Elaprase in HGT-HIT-045 and had evaluable samples were analyzed for this outcome measure. Number analyzed indicates the number of participants with data available for analyses at the specified time point.
Volume of distribution associated with the terminal slope (Vz) of Elaprase was assessed.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=2 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
Volume of Distribution (Vz) of Elaprase
Week 3: Day 3-7
|
19.91 liters
Standard Deviation 13.874
|
—
|
—
|
|
Volume of Distribution (Vz) of Elaprase
Week 23: Day 3-7
|
34.20 liters
Standard Deviation NA
SD was not estimable for a single participant.
|
—
|
—
|
SECONDARY outcome
Timeframe: 15 minutes prior to IV infusion and at multiple timepoints (0.5, 1, 1.5, 2, 2.5, and 3 hours during the infusion; and at 3.5, 4, 5, 6, 7, 9, 11, and 24 hours) following IV infusion on Days 3-7 of Weeks 3 and 23Population: Participants who received only Elaprase in HGT-HIT-045 and had evaluable samples were analyzed for this outcome measure. Number analyzed indicates the number of participants with data available for analyses at the specified time point.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=2 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
Mean Residence Time Extrapolated to Infinity (MRT0-inf) of Elaprase
Week 3: Day 3-7
|
6.49 hours
Standard Deviation 3.817
|
—
|
—
|
|
Mean Residence Time Extrapolated to Infinity (MRT0-inf) of Elaprase
Week 23: Day 3-7
|
3.80 hours
Standard Deviation NA
SD was not estimable for a single participant.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 7, 55, and 139Population: Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. Number analyzed is the number of participants with data available for analyses. A few participants from the 1 mg arm had transitioned to 10 mg arm before the analysis at Month 7 was performed for this outcome measure.
Change from baseline in CSF biomarkers glycosaminoglycan (GAG \[heparan sulfate (HS)/dermatan sulfate (DS)\]) was assessed.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=4 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
n=10 Participants
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
n=5 Participants
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
Change From Baseline in CSF Biomarkers
Baseline
|
1922.34 ng/mL
Standard Deviation 1164.679
|
1874.00 ng/mL
Standard Deviation 979.459
|
1111.92 ng/mL
Standard Deviation 485.898
|
|
Change From Baseline in CSF Biomarkers
Change from Baseline at Month 7
|
-807.50 ng/mL
Standard Deviation 569.461
|
-1526.24 ng/mL
Standard Deviation 638.893
|
-987.65 ng/mL
Standard Deviation 437.885
|
|
Change From Baseline in CSF Biomarkers
Change from Baseline at Month 55
|
—
|
-1575.63 ng/mL
Standard Deviation 906.621
|
-974.07 ng/mL
Standard Deviation 558.075
|
|
Change From Baseline in CSF Biomarkers
Change from Baseline at Month 139
|
—
|
-1169.25 ng/mL
Standard Deviation 530.781
|
-1135.51 ng/mL
Standard Deviation NA
SD was not estimable for a single participant.
|
SECONDARY outcome
Timeframe: Baseline, Months 7, 55, and 163Population: Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. Number analyzed is the number of participants with data available for analyses.
mg GAG/mmol creatinine stands for milligrams of GAG per millimole of creatinine.
Outcome measures
| Measure |
Idursulfase-IT 1 mg
n=4 Participants
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
n=10 Participants
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
n=5 Participants
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
Change From Baseline in Urinary Glycosaminoglycan (GAG)
Change from Baseline at Month 7
|
5.22 mg GAG/mmol creatinine
Standard Deviation 6.084
|
-4.20 mg GAG/mmol creatinine
Standard Deviation 4.278
|
3.35 mg GAG/mmol creatinine
Standard Deviation 1.324
|
|
Change From Baseline in Urinary Glycosaminoglycan (GAG)
Change from Baseline at Month 55
|
—
|
-6.83 mg GAG/mmol creatinine
Standard Deviation 5.837
|
6.33 mg GAG/mmol creatinine
Standard Deviation 7.387
|
|
Change From Baseline in Urinary Glycosaminoglycan (GAG)
Change from Baseline at Month 163
|
—
|
-13.88 mg GAG/mmol creatinine
Standard Deviation 5.163
|
—
|
|
Change From Baseline in Urinary Glycosaminoglycan (GAG)
Baseline
|
34.07 mg GAG/mmol creatinine
Standard Deviation 20.132
|
23.35 mg GAG/mmol creatinine
Standard Deviation 13.799
|
13.67 mg GAG/mmol creatinine
Standard Deviation 7.200
|
Adverse Events
Idursulfase-IT 1 mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Idursulfase-IT 10 mg
Serious events: 9 serious events
Other events: 10 other events
Deaths: 0 deaths
Idursulfase-IT 30 mg
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Idursulfase-IT 1 mg
n=4 participants at risk
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
n=10 participants at risk
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
n=5 participants at risk
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Tracheostomy malfunction
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Vascular complication associated with device
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Viral infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Wound haematoma
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Atonic seizures
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
CSF white blood cell count increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Central nervous system infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Device breakage
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Device connection issue
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Device difficult to use
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Device dislocation
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Device failure
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
50.0%
5/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Device malfunction
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Device occlusion
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Device related infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Feeding tube complication
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Granuloma
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Implant site infection
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Overgrowth bacterial
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Pain
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Vascular disorders
Pallor
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Resorption bone increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Seizure like phenomena
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
Other adverse events
| Measure |
Idursulfase-IT 1 mg
n=4 participants at risk
Participants received 1 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 10.1 months.
|
Idursulfase-IT 10 mg
n=10 participants at risk
Participants received 10 mg idursulfase-IT initially intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions up to a maximum of 157.2 months. This included participants who received 1 mg idursulfase-IT initially and then switched to receive 10 mg idursulfase-IT in this arm group after Month 7 or later. These participants were analyzed in this arm group since transition to this group.
|
Idursulfase-IT 30 mg
n=5 participants at risk
Participants received 30 mg idursulfase-IT intrathecally via IDDD or LP once monthly and SoC therapy of Elaprase IV infusions for up to a maximum of 148.2 months.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Accidental exposure to product
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Aggression
|
50.0%
2/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Agitation
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
80.0%
8/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Agitation postoperative
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
50.0%
5/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Angiokeratoma
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Blood and lymphatic system disorders
Anisocytosis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Anorectal infection
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Anticipatory anxiety
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Antisocial behaviour
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Application site erythema
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Aptyalism
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
50.0%
5/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Asthenia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Bacterial test
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Bacterial test positive
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Bacterial tracheitis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Band neutrophil count increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Base excess decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Bite
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Blood calcium decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Blood chloride increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Blood pressure decreased
|
50.0%
2/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
70.0%
7/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Blood pressure diastolic decreased
|
50.0%
2/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
80.0%
8/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Blood pressure diastolic increased
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
80.0%
8/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Vascular disorders
Blood pressure fluctuation
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Blood pressure increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
6/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Blood pressure systolic decreased
|
50.0%
2/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
70.0%
7/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Blood pressure systolic increased
|
50.0%
2/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
80.0%
8/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Blood sodium increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Blood triglycerides increased
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Blood urea increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Vascular disorders
Bloody discharge
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Body temperature decreased
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
6/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Body temperature increased
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Bone density decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchomalacia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Burns first degree
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
CSF cell count increased
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
70.0%
7/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
CSF culture positive
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
CSF glucose decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
CSF lymphocyte count increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
CSF neutrophil count positive
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
CSF protein decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
CSF protein increased
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
70.0%
7/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
CSF white blood cell count increased
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Candida nappy rash
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Carbon dioxide decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Cardiac murmur
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
80.0%
4/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
50.0%
5/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Catheter site bruise
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Catheter site erythema
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Cerebral atrophy
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Cerebral ventricle dilatation
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
6/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Chills
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Clonus
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Congenital, familial and genetic disorders
Congenital bowing of long bones
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
70.0%
7/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Contusion
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
80.0%
8/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
6/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Coronavirus test positive
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
80.0%
8/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Crepitations
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Crystal urine present
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Cyst
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Decreased activity
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
50.0%
5/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
6/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Depressed mood
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Device breakage
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Device connection issue
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Device dislocation
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Device malfunction
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Device occlusion
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
80.0%
8/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Discomfort
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Drooling
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
50.0%
2/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Dyskinesia
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Congenital, familial and genetic disorders
Dysmorphism
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Dysphemia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Ear infection
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
70.0%
7/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Ear and labyrinth disorders
Ear pain
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Eating disorder
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Eye disorders
Eczema eyelids
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Electroencephalogram abnormal
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Energy increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Enterobiasis
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Renal and urinary disorders
Enuresis
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
70.0%
7/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
80.0%
4/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Exposure via ingestion
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Extravasation
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Eye disorders
Eye discharge
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Eye infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Eye disorders
Eye irritation
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Eye disorders
Eye swelling
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Eyelid infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Eye disorders
Eyelid margin crusting
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Face oedema
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
6/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
80.0%
4/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Fatigue
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Furuncle
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Gait disturbance
|
50.0%
2/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
6/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Generalised oedema
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Eye disorders
Glaucoma
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Head injury
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Heart rate decreased
|
50.0%
2/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
80.0%
8/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Heart rate increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Heart rate irregular
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Heart sounds abnormal
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Herpes zoster
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Human bite
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Hyperreflexia
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Hypersomnia
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Hypertonia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Blood and lymphatic system disorders
Hypochromasia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Hypothermia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Impetigo
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Implant site effusion
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Implant site erythema
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Implant site infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Implant site pain
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Implant site rash
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Implant site reaction
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Implant site scar
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Implant site swelling
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Impulsive behaviour
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Influenza like illness
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Infusion site bruising
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Iron binding capacity total decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Irritability
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Knee deformity
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Labyrinthitis
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Cardiac disorders
Left atrial dilatation
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Cardiac disorders
Left atrial hypertrophy
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Blood and lymphatic system disorders
Leukocyte vacuolisation
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Lice infestation
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Local swelling
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Localised infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Loose tooth
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Lymphocyte morphology abnormal
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Congenital, familial and genetic disorders
Macrogenia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Malaise
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Mastication disorder
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Ear and labyrinth disorders
Mastoid disorder
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Ear and labyrinth disorders
Mastoid effusion
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Mean cell haemoglobin concentration decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Mean cell haemoglobin decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Mean cell volume abnormal
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Mean cell volume decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Medical device complication
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Blood and lymphatic system disorders
Microcytosis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Cardiac disorders
Mitral valve stenosis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Monocyte count decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Monocyte morphology abnormal
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Ear and labyrinth disorders
Motion sickness
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Movement disorder
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Nail infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
50.0%
2/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
50.0%
5/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal odour
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Nasogastric output abnormal
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
80.0%
8/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Negativism
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Nitrite urine present
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Nuclear magnetic resonance imaging abnormal
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Nuclear magnetic resonance imaging brain abnormal
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Otitis media
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
50.0%
5/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Ear and labyrinth disorders
Otorrhoea
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
50.0%
5/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
70.0%
7/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
PCO2 decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Pain
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
50.0%
5/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Vascular disorders
Pallor
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Eye disorders
Papilloedema
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Parkinsonian gait
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Paronychia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Reproductive system and breast disorders
Penile erythema
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Personality change
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal disorder
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Metabolism and nutrition disorders
Pica
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Posture abnormal
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
100.0%
4/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
80.0%
8/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
100.0%
5/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Protein total decreased
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Protein total increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Protein urine
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Protein urine present
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Protrusion tongue
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Pseudomonas test positive
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Blood and lymphatic system disorders
Punctate basophilia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Puncture site pain
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Eye disorders
Pupils unequal
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Pyramidal tract syndrome
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Pyrexia
|
75.0%
3/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
90.0%
9/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
100.0%
5/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
70.0%
7/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Red blood cell burr cells present
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Red blood cell count increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Red blood cells CSF positive
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Red blood cells urine
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Red cell distribution width increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Red man syndrome
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Regressive behaviour
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Respiratory rate decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Respiratory rate increased
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Restlessness
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
50.0%
5/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Eye disorders
Retinal deposits
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Rhinitis
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
6/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Cardiac disorders
Right ventricular hypertrophy
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Scarlet fever
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Scratch
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Immune system disorders
Seasonal allergy
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Cardiac disorders
Sinus tachycardia
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
50.0%
5/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Skin candida
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Congenital, familial and genetic disorders
Skull malformation
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Sleep study abnormal
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Social avoidant behaviour
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord neoplasm
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Splinter
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Psychiatric disorders
Staring
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Streptococcus test positive
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Syncope
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Reproductive system and breast disorders
Testicular swelling
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Congenital, familial and genetic disorders
Thalassaemia beta
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Thirst
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Thyroid function test abnormal
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Thyroxine decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Thyroxine increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Toe walking
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
50.0%
5/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Tooth crowding
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Surgical and medical procedures
Tooth extraction
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Tooth socket haemorrhage
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal disorder
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Tracheal haemorrhage
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheomalacia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Tracheostomy malfunction
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Transferrin decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Transferrin saturation increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Traumatic lumbar puncture
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Ear and labyrinth disorders
Tympanic membrane hyperaemia
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Umbilical hernia
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
30.0%
3/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Upper respiratory tract infection
|
75.0%
3/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
80.0%
8/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
80.0%
4/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Renal and urinary disorders
Urinary incontinence
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Urine output decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Urobilinogen urine increased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
2/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
General disorders
Vascular complication associated with device
|
25.0%
1/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
70.0%
7/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
100.0%
5/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
100.0%
10/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
80.0%
4/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
4/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
|
Investigations
Xanthochromia
|
0.00%
0/4 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
10.0%
1/10 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 165 months)
Safety Population included all eligible participants from HGT-HIT-045 who had agreed to participate in the extension study and have had either surgical implantation of an IDDD or intrathecal administration of study drug in the extension study. For Idursulfase-IT 1 mg+10 mg arm the AEs includes only the AEs that occurred while the participants were assigned to 10 mg.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place