Trial Outcomes & Findings for A Study of Intrathecal SHP611 in Children With Metachromatic Leukodystrophy (NCT NCT03771898)
NCT ID: NCT03771898
Last Updated: 2026-01-26
Results Overview
Loss of locomotion was estimated using interval censoring survival analysis. Survival probability free of loss of locomotion based on GMFC-MLD was estimated up to Week 106 (or two years), with associated 2-sided 95 percent (%) confidence interval (CI). GMFC-MLD scale consists of 7 categories, scores ranging from 0 (walking without support with quality of performance normal for age) to 6 (loss of any locomotion as well as loss of any head and trunk control). Higher scores mean a worse outcome. The data was reported in terms of Mean as survival function was quantified using a weighted average of percentage of participants not reaching the event of interest, with weights derived from the relative size of treated and control units in the strata used for the stratified log-rank test in the primary analysis.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Baseline up to Week 106
Results posted on
2026-01-26
Participant Flow
The study was conducted at 19 investigational sites. A total of 36 participants were enrolled in this two-period study (primary treatment and extension periods) of which 35 received SHP611 or had intrathecal drug delivery device (IDDD) implanted. Data was reported till the primary treatment period. The study is still ongoing, additional data will be reported after the completion of the study. Study consisted of six groups (Group A,B,C,D, E, F) based on participant's age and motor dysfunction.
No participants were enrolled in Groups D and E, hence no data was collected or reported for these two groups. For efficacy analysis, Group A arm of current study was compared with matched external control group (33 participants) data from untreated metachromatic leukodystrophy (MLD) participants in the Global Leukodystrophy Initiative natural history study (GLIA-MLD), part of the Global Leukodystrophy Initiative Clinical Trials Network (GLIA-CTN, NCT03047369).
Participant milestones
| Measure |
Group A, SHP611
Participants aged 18 to 48 months with Gross Motor Function Classification in Metachromatic Leukodystrophy (GMFC-MLD) Category of 1 or 2 received SHP611 150 milligrams (mg) intrathecally (IT) via IDDD or lumbar puncture (LP), once weekly for 106 weeks in primary treatment period. Participants who completed primary treatment period will be continued treatment in extension period up to Week 210 or beyond, until their parents/guardians decided to discontinue treatment; the sponsor discontinued the study; the participant discontinued from the study due to medical or safety concerns; or the product became commercially available in the participant's country of residence, whichever came first.
|
Group B, SHP611
Participants aged 18 to 72 months with GMFC-MLD Category of 3 received SHP611 150 mg IT via IDDD or LP once weekly for 106 weeks in primary treatment period. Participants who completed primary treatment period will be continued treatment in extension period up to Week 210 or beyond, until their parents/guardians decided to discontinue treatment; the sponsor discontinued the study; the participant discontinued from the study due to medical or safety concerns; or the product became commercially available in the participant's country of residence, whichever came first.
|
Group C, SHP611
Participants aged 18 to 72 months with GMFC-MLD Category of 4 received SHP611 150 mg IT via IDDD or LP once weekly for 106 weeks in primary treatment period. Participants who completed primary treatment period will be continued treatment in extension period up to Week 210 or beyond, until their parents/guardians decided to discontinue treatment; the sponsor discontinued the study; the participant discontinued from the study due to medical or safety concerns; or the product became commercially available in the participant's country of residence, whichever came first.
|
Group F, SHP611
Participants aged 18 to 72 months with GMFC-MLD Category of 5 or 6 received SHP611 150 mg IT via IDDD or LP once weekly for 106 weeks in primary treatment period. Participants who completed primary treatment period will be continued treatment in extension period up to Week 210 or beyond, until their parents/guardians decided to discontinue treatment; the sponsor discontinued the study; the participant discontinued from the study due to medical or safety concerns; or the product became commercially available in the participant's country of residence, whichever came first.
|
GLIA-MLD Matched External Control for Group A
Group A matched external control group of untreated MLD participants (who have received no investigational product or therapy) from the ongoing GLIA-MLD retrospective natural history study with exact matching GMFC-MLD score with Group A were selected. The GLIA-MLD natural history study database was used as source data for external control matching group participants for efficacy comparison.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
5
|
6
|
9
|
33
|
|
Overall Study
COMPLETED
|
12
|
3
|
5
|
9
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
1
|
0
|
33
|
Reasons for withdrawal
| Measure |
Group A, SHP611
Participants aged 18 to 48 months with Gross Motor Function Classification in Metachromatic Leukodystrophy (GMFC-MLD) Category of 1 or 2 received SHP611 150 milligrams (mg) intrathecally (IT) via IDDD or lumbar puncture (LP), once weekly for 106 weeks in primary treatment period. Participants who completed primary treatment period will be continued treatment in extension period up to Week 210 or beyond, until their parents/guardians decided to discontinue treatment; the sponsor discontinued the study; the participant discontinued from the study due to medical or safety concerns; or the product became commercially available in the participant's country of residence, whichever came first.
|
Group B, SHP611
Participants aged 18 to 72 months with GMFC-MLD Category of 3 received SHP611 150 mg IT via IDDD or LP once weekly for 106 weeks in primary treatment period. Participants who completed primary treatment period will be continued treatment in extension period up to Week 210 or beyond, until their parents/guardians decided to discontinue treatment; the sponsor discontinued the study; the participant discontinued from the study due to medical or safety concerns; or the product became commercially available in the participant's country of residence, whichever came first.
|
Group C, SHP611
Participants aged 18 to 72 months with GMFC-MLD Category of 4 received SHP611 150 mg IT via IDDD or LP once weekly for 106 weeks in primary treatment period. Participants who completed primary treatment period will be continued treatment in extension period up to Week 210 or beyond, until their parents/guardians decided to discontinue treatment; the sponsor discontinued the study; the participant discontinued from the study due to medical or safety concerns; or the product became commercially available in the participant's country of residence, whichever came first.
|
Group F, SHP611
Participants aged 18 to 72 months with GMFC-MLD Category of 5 or 6 received SHP611 150 mg IT via IDDD or LP once weekly for 106 weeks in primary treatment period. Participants who completed primary treatment period will be continued treatment in extension period up to Week 210 or beyond, until their parents/guardians decided to discontinue treatment; the sponsor discontinued the study; the participant discontinued from the study due to medical or safety concerns; or the product became commercially available in the participant's country of residence, whichever came first.
|
GLIA-MLD Matched External Control for Group A
Group A matched external control group of untreated MLD participants (who have received no investigational product or therapy) from the ongoing GLIA-MLD retrospective natural history study with exact matching GMFC-MLD score with Group A were selected. The GLIA-MLD natural history study database was used as source data for external control matching group participants for efficacy comparison.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by parent/guardian
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Ongoing (Participants in GLIA-MLD, [part of GLIA-CTN study])
|
0
|
0
|
0
|
0
|
33
|
Baseline Characteristics
A Study of Intrathecal SHP611 in Children With Metachromatic Leukodystrophy
Baseline characteristics by cohort
| Measure |
Group A, SHP611
n=15 Participants
Participants aged 18 to 48 months with Gross Motor Function Classification in Metachromatic Leukodystrophy (GMFC-MLD) Category of 1 or 2 received SHP611 150 milligrams (mg) intrathecally (IT) via IDDD or lumbar puncture (LP), once weekly for 106 weeks in primary treatment period. Participants who completed primary treatment period will be continued treatment in extension period up to Week 210 or beyond, until their parents/guardians decided to discontinue treatment; the sponsor discontinued the study; the participant discontinued from the study due to medical or safety concerns; or the product became commercially available in the participant's country of residence, whichever came first.
|
Group B, SHP611
n=5 Participants
Participants aged 18 to 72 months with GMFC-MLD Category of 3 received SHP611 150 mg IT via IDDD or LP once weekly for 106 weeks in primary treatment period. Participants who completed primary treatment period will be continued treatment in extension period up to Week 210 or beyond, until their parents/guardians decided to discontinue treatment; the sponsor discontinued the study; the participant discontinued from the study due to medical or safety concerns; or the product became commercially available in the participant's country of residence, whichever came first.
|
Group C, SHP611
n=6 Participants
Participants aged 18 to 72 months with GMFC-MLD Category of 4 received SHP611 150 mg IT via IDDD or LP once weekly for 106 weeks in primary treatment period. Participants who completed primary treatment period will be continued treatment in extension period up to Week 210 or beyond, until their parents/guardians decided to discontinue treatment; the sponsor discontinued the study; the participant discontinued from the study due to medical or safety concerns; or the product became commercially available in the participant's country of residence, whichever came first.
|
Group F, SHP611
n=9 Participants
Participants aged 18 to 72 months with GMFC-MLD Category of 5 or 6 received SHP611 150 mg IT via IDDD or LP once weekly for 106 weeks in primary treatment period. Participants who completed primary treatment period will be continued treatment in extension period up to Week 210 or beyond, until their parents/guardians decided to discontinue treatment; the sponsor discontinued the study; the participant discontinued from the study due to medical or safety concerns; or the product became commercially available in the participant's country of residence, whichever came first.
|
GLIA-MLD Matched External Control for Group A
n=33 Participants
Group A matched external control group of untreated MLD participants (who have received no investigational product or therapy) from the ongoing GLIA-MLD retrospective natural history study with exact matching GMFC-MLD score with Group A were selected. The GLIA-MLD natural history study database was used as source data for external control matching group participants for efficacy comparison.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
18.27 months
STANDARD_DEVIATION 4.008 • n=25 Participants
|
20.80 months
STANDARD_DEVIATION 4.658 • n=25 Participants
|
17.67 months
STANDARD_DEVIATION 7.448 • n=50 Participants
|
17.44 months
STANDARD_DEVIATION 4.746 • n=152 Participants
|
14.76 months
STANDARD_DEVIATION 3.751 • n=614 Participants
|
16.59 months
STANDARD_DEVIATION 4.692 • n=31 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=25 Participants
|
4 Participants
n=25 Participants
|
2 Participants
n=50 Participants
|
4 Participants
n=152 Participants
|
15 Participants
n=614 Participants
|
36 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
4 Participants
n=50 Participants
|
5 Participants
n=152 Participants
|
18 Participants
n=614 Participants
|
32 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=152 Participants
|
2 Participants
n=614 Participants
|
8 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=25 Participants
|
4 Participants
n=25 Participants
|
2 Participants
n=50 Participants
|
8 Participants
n=152 Participants
|
9 Participants
n=614 Participants
|
31 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
3 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
22 Participants
n=614 Participants
|
29 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
1 Participants
n=614 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=152 Participants
|
1 Participants
n=614 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
0 Participants
n=614 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=152 Participants
|
1 Participants
n=614 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=25 Participants
|
5 Participants
n=25 Participants
|
5 Participants
n=50 Participants
|
7 Participants
n=152 Participants
|
13 Participants
n=614 Participants
|
42 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
0 Participants
n=614 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
17 Participants
n=614 Participants
|
18 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 106Population: The modified full analysis set (mFAS) included all participants from Group A who received at least 1 dose of SHP611 and had at least a screening GMFC-MLD assessment, and the matched external control participants for Group A from GLIA-MLD natural history study. As per planned analysis, this outcome measure was assessed in Group A and GLIA-MLD matched external control for Group A.
Loss of locomotion was estimated using interval censoring survival analysis. Survival probability free of loss of locomotion based on GMFC-MLD was estimated up to Week 106 (or two years), with associated 2-sided 95 percent (%) confidence interval (CI). GMFC-MLD scale consists of 7 categories, scores ranging from 0 (walking without support with quality of performance normal for age) to 6 (loss of any locomotion as well as loss of any head and trunk control). Higher scores mean a worse outcome. The data was reported in terms of Mean as survival function was quantified using a weighted average of percentage of participants not reaching the event of interest, with weights derived from the relative size of treated and control units in the strata used for the stratified log-rank test in the primary analysis.
Outcome measures
| Measure |
Group A, SHP611
n=15 Participants
Participants aged 18 to 48 months with Gross Motor Function Classification in Metachromatic Leukodystrophy (GMFC-MLD) Category of 1 or 2 received SHP611 150 milligrams (mg) intrathecally (IT) via IDDD or lumbar puncture (LP), once weekly for 106 weeks in primary treatment period. Participants who completed primary treatment period will be continued treatment in extension period up to Week 210 or beyond, until their parents/guardians decided to discontinue treatment; the sponsor discontinued the study; the participant discontinued from the study due to medical or safety concerns; or the product became commercially available in the participant's country of residence, whichever came first.
|
GLIA-MLD Matched External Control for Group A
n=33 Participants
Group A matched external control group of untreated MLD participants (who have received no investigational product or therapy) from the ongoing GLIA-MLD retrospective natural history study with exact matching GMFC-MLD score with Group A were selected. The GLIA-MLD natural history study database was used as source data for external control matching group participants for efficacy comparison.
|
|---|---|---|
|
Percent Probability of Free of Loss of Locomotion in the Last Time Interval Up to 2 Years (Week 106) Based on GMFC-MLD for SHP611 Group A and GLIA-MLD Matched External Control
|
7.1 percent probability
Interval 0.0 to 20.2
|
9.4 percent probability
Interval 0.0 to 24.4
|
SECONDARY outcome
Timeframe: Baseline up to Week 106Data collection is ongoing and detailed reporting will be available after the study completion date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 106Data collection is ongoing and detailed reporting will be available after the study completion date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 106Data collection is ongoing and detailed reporting will be available after the study completion date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 106Data collection is ongoing and detailed reporting will be available after the study completion date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 106Data collection is ongoing and detailed reporting will be available after the study completion date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 106Data collection is ongoing and detailed reporting will be available after the study completion date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 106Data collection is ongoing and detailed reporting will be available after the study completion date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 106Data collection is ongoing and detailed reporting will be available after the study completion date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 106Data collection is ongoing and detailed reporting will be available after the study completion date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 106Data collection is ongoing and detailed reporting will be available after the study completion date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 106Data collection is ongoing and detailed reporting will be available after the study completion date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of study drug administration up to Week 106Data collection is ongoing and detailed reporting will be available after the study completion date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 106Data collection is ongoing and detailed reporting will be available after the study completion date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 106Data collection is ongoing and detailed reporting will be available after the study completion date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 106Data collection is ongoing and detailed reporting will be available after the study completion date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 106Data collection is ongoing and detailed reporting will be available after the study completion date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 106Data collection is ongoing and detailed reporting will be available after the study completion date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 106Data collection is ongoing and detailed reporting will be available after the study completion date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 106Data collection is ongoing and detailed reporting will be available after the study completion date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 106Data collection is ongoing and detailed reporting will be available after the study completion date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 106Data collection is ongoing and detailed reporting will be available after the study completion date.
Outcome measures
Outcome data not reported
Adverse Events
Group A, SHP611
Serious events: 14 serious events
Other events: 15 other events
Deaths: 0 deaths
Group B, SHP611
Serious events: 4 serious events
Other events: 5 other events
Deaths: 1 deaths
Group C, SHP611
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Group F, SHP611
Serious events: 9 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A, SHP611
n=15 participants at risk
Participants aged 18 to 48 months with GMFC-MLD Category of 1 or 2 received SHP611 150 mg IT via IDDD or LP once weekly for 106 weeks in primary treatment period. Participants who completed primary treatment period will be continued treatment in extension period up to Week 210 or beyond, until their parents/guardians decided to discontinue treatment; the sponsor discontinued the study; the participant discontinued from the study due to medical or safety concerns; or the product became commercially available in the participant's country of residence, whichever came first.
|
Group B, SHP611
n=5 participants at risk
Participants aged 18 to 72 months with GMFC-MLD Category of 3 received SHP611 150 mg IT via IDDD or LP once weekly for 106 weeks in primary treatment period. Participants who completed primary treatment period will be continued treatment in extension period up to Week 210 or beyond, until their parents/guardians decided to discontinue treatment; the sponsor discontinued the study; the participant discontinued from the study due to medical or safety concerns; or the product became commercially available in the participant's country of residence, whichever came first.
|
Group C, SHP611
n=6 participants at risk
Participants aged 18 to 72 months with GMFC-MLD Category of 4 received SHP611 150 mg IT via IDDD or LP once weekly for 106 weeks in primary treatment period. Participants who completed primary treatment period will be continued treatment in extension period up to Week 210 or beyond, until their parents/guardians decided to discontinue treatment; the sponsor discontinued the study; the participant discontinued from the study due to medical or safety concerns; or the product became commercially available in the participant's country of residence, whichever came first.
|
Group F, SHP611
n=9 participants at risk
Participants aged 18 to 72 months with GMFC-MLD Category of 5 or 6 received SHP611 150 mg IT via IDDD or LP once weekly for 106 weeks in primary treatment period. Participants who completed primary treatment period will be continued treatment in extension period up to Week 210 or beyond, until their parents/guardians decided to discontinue treatment; the sponsor discontinued the study; the participant discontinued from the study due to medical or safety concerns; or the product became commercially available in the participant's country of residence, whichever came first.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Psychiatric disorders
Agitation
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Bacterial test positive
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Bronchitis viral
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
CNS ventriculitis
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
COVID-19
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
CSF eosinophil count increased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Central nervous system infection
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Croup infectious
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Metabolism and nutrition disorders
Dehydration
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Product Issues
Device breakage
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Product Issues
Device dislocation
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Product Issues
Device failure
|
26.7%
4/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Product Issues
Device leakage
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Product Issues
Device malfunction
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Device related infection
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
3/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
40.0%
2/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Psychiatric disorders
Eating disorder
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Epilepsy
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Escherichia urinary tract infection
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Febrile convulsion
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
2/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Febrile infection
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Metabolism and nutrition disorders
Feeding disorder
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Gastroenteritis
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Implant site oedema
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Influenza
|
20.0%
3/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Immune system disorders
Infusion related hypersensitivity reaction
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Meningitis
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Pain
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
40.0%
2/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Parainfluenzae viral bronchitis
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Pleocytosis
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
3/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Procedural failure
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Pyrexia
|
26.7%
4/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
2/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
44.4%
4/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
3/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Respiratory tract infection
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Seizure
|
20.0%
3/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
66.7%
4/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
55.6%
5/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Sepsis
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Staphylococcal infection
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Status epilepticus
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
50.0%
3/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Renal and urinary disorders
Urinary retention
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Viral infection
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
Other adverse events
| Measure |
Group A, SHP611
n=15 participants at risk
Participants aged 18 to 48 months with GMFC-MLD Category of 1 or 2 received SHP611 150 mg IT via IDDD or LP once weekly for 106 weeks in primary treatment period. Participants who completed primary treatment period will be continued treatment in extension period up to Week 210 or beyond, until their parents/guardians decided to discontinue treatment; the sponsor discontinued the study; the participant discontinued from the study due to medical or safety concerns; or the product became commercially available in the participant's country of residence, whichever came first.
|
Group B, SHP611
n=5 participants at risk
Participants aged 18 to 72 months with GMFC-MLD Category of 3 received SHP611 150 mg IT via IDDD or LP once weekly for 106 weeks in primary treatment period. Participants who completed primary treatment period will be continued treatment in extension period up to Week 210 or beyond, until their parents/guardians decided to discontinue treatment; the sponsor discontinued the study; the participant discontinued from the study due to medical or safety concerns; or the product became commercially available in the participant's country of residence, whichever came first.
|
Group C, SHP611
n=6 participants at risk
Participants aged 18 to 72 months with GMFC-MLD Category of 4 received SHP611 150 mg IT via IDDD or LP once weekly for 106 weeks in primary treatment period. Participants who completed primary treatment period will be continued treatment in extension period up to Week 210 or beyond, until their parents/guardians decided to discontinue treatment; the sponsor discontinued the study; the participant discontinued from the study due to medical or safety concerns; or the product became commercially available in the participant's country of residence, whichever came first.
|
Group F, SHP611
n=9 participants at risk
Participants aged 18 to 72 months with GMFC-MLD Category of 5 or 6 received SHP611 150 mg IT via IDDD or LP once weekly for 106 weeks in primary treatment period. Participants who completed primary treatment period will be continued treatment in extension period up to Week 210 or beyond, until their parents/guardians decided to discontinue treatment; the sponsor discontinued the study; the participant discontinued from the study due to medical or safety concerns; or the product became commercially available in the participant's country of residence, whichever came first.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Adverse drug reaction
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Psychiatric disorders
Agitation
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Albumin CSF increased
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
50.0%
3/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
3/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Amylase increased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Anal inflammation
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Eye disorders
Anisocoria
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Anticonvulsant drug level abnormal
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Aphasia
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Areflexia
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
2/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Asthenia
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Bacteraemia
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Bacterial disease carrier
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Bacterial test
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Balance disorder
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Eye disorders
Blepharitis
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Blood albumin increased
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Blood iron increased
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Blood pressure increased
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Blood urine present
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
2/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Body temperature decreased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Body temperature increased
|
20.0%
3/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Musculoskeletal and connective tissue disorders
Bone demineralisation
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Psychiatric disorders
Breathing-related sleep disorder
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Bronchiolitis
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Bronchitis
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
2/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Psychiatric disorders
Bruxism
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
COVID-19
|
66.7%
10/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
50.0%
3/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
CSF eosinophil count increased
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
CSF glucose decreased
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
CSF monocyte count increased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
CSF mononuclear cell count increased
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
CSF neutrophil count increased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
CSF protein increased
|
46.7%
7/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
50.0%
3/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
66.7%
6/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
CSF red blood cell count positive
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
CSF test abnormal
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
CSF white blood cell count increased
|
26.7%
4/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
2/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Catheter site bruise
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Catheter site dermatitis
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Catheter site erythema
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Catheter site mass
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Catheter site swelling
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Cerebellar atrophy
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Cerebral atrophy
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Cerebral ventricle dilatation
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Cerebrospinal fistula
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
3/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Eye disorders
Chalazion
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
2/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Hepatobiliary disorders
Cholelithiasis
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Chorea
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Complication associated with device
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Conjunctivitis
|
20.0%
3/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Constipation
|
80.0%
12/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
60.0%
3/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
66.7%
4/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
55.6%
5/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Coordination abnormal
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Coronavirus test
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
6/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
40.0%
2/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
55.6%
5/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Croup infectious
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Crying
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Crystal urine present
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Culture positive
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Vascular disorders
Cyanosis
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Decerebrate posture
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
3/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Psychiatric disorders
Decreased eye contact
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Demyelination
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Dental caries
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Developmental delay
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Congenital, familial and genetic disorders
Developmental hip dysplasia
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Product Issues
Device dislocation
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Product Issues
Device kink
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Product Issues
Device leakage
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Device related infection
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
5/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
44.4%
4/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Discomfort
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Psychiatric disorders
Disorganised speech
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Drooling
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Eye disorders
Dry eye
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Dumping syndrome
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Dysarthria
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Dyskinesia
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
5/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
50.0%
3/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
3/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Dysstasia
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Dystonia
|
26.7%
4/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Ear infection
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Psychiatric disorders
Eating disorder
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Electroencephalogram abnormal
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Epilepsy
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
2/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Eye disorders
Erythema of eyelid
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Eye disorders
Eye disorder
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Eye disorders
Eye movement disorder
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Eye disorders
Eye pain
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Eye disorders
Eye swelling
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Eyelid injury
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Facial pain
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Fatigue
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
66.7%
4/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Febrile infection
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Metabolism and nutrition disorders
Feeding disorder
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Flatulence
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Metabolism and nutrition disorders
Food refusal
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Fungal foot infection
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Gait disturbance
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Gait spastic
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Hepatobiliary disorders
Gallbladder enlargement
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
2/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
44.4%
4/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Gastroenteritis
|
33.3%
5/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
66.7%
4/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Gastroenteritis viral
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Gastrointestinal infection
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
33.3%
5/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
60.0%
3/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
2/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
3/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Eye disorders
Gaze palsy
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Granuloma
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Haematocrit increased
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Vascular disorders
Haematoma
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Haemoglobin increased
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Head injury
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Heart rate decreased
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Heart rate increased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Hepatic enzyme abnormal
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Musculoskeletal and connective tissue disorders
Hip deformity
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Hordeolum
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Human bocavirus infection
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Hypertonia
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Metabolism and nutrition disorders
Hypophagia
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Vascular disorders
Hypotension
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Hypotonia
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Implant site oedema
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Incision site swelling
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Psychiatric disorders
Insomnia
|
20.0%
3/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
40.0%
2/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of upper respiratory secretion
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Infantile spitting up
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Infection
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Influenza
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Immune system disorders
Infusion related hypersensitivity reaction
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Psychiatric disorders
Irritability
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
40.0%
2/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
3/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Musculoskeletal and connective tissue disorders
Joint hyperextension
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Labyrinthitis
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Laryngitis viral
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Lethargy
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Congenital, familial and genetic disorders
Leukodystrophy
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Musculoskeletal and connective tissue disorders
Lordosis
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Malaise
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Metabolism and nutrition disorders
Malnutrition
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Medical device site granuloma
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Medical device site haemorrhage
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Medical device site infection
|
20.0%
3/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Medical device site irritation
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Medical device site swelling
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Immune system disorders
Mite allergy
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Moaning
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Motor dysfunction
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Muscle enzyme increased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Muscle spasticity
|
73.3%
11/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
60.0%
3/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
2/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
66.7%
6/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Eye disorders
Myopia
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
3/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Nasopharyngitis
|
40.0%
6/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Neuralgia
|
20.0%
3/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Neuropathy peripheral
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Nitrite urine
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Nitrite urine present
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Nodule
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Oedema peripheral
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Eye disorders
Optic atrophy
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Oral candidiasis
|
20.0%
3/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Oral pain
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Otitis media
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Otitis media acute
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
3/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Pain
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
44.4%
4/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
3/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Paronychia
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Partial seizures
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
2/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Pleocytosis
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Plicated tongue
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Pneumonia
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
2/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
44.4%
4/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Pre-existing condition improved
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Endocrine disorders
Precocious puberty
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Psychiatric disorders
Procedural anxiety
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
53.3%
8/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
44.4%
4/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Protein urine
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Protein urine present
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
3/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
General disorders
Pyrexia
|
86.7%
13/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
60.0%
3/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
66.7%
4/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
100.0%
9/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Rash
|
40.0%
6/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
40.0%
2/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Red blood cell count increased
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Psychiatric disorders
Regressive behaviour
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Regurgitation
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
2/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Psychiatric disorders
Restlessness
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Retching
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Eye disorders
Retinal dystrophy
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Rhinitis
|
20.0%
3/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
50.0%
3/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
3/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
26.7%
4/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
40.0%
2/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
3/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
20.0%
3/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
60.0%
3/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
50.0%
3/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
3/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Scratch
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Immune system disorders
Seasonal allergy
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Seizure
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
2/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
44.4%
4/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Seizure cluster
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Skin candida
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Sleep deficit
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Psychiatric disorders
Sleep disorder
|
26.7%
4/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Somnolence
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
2/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Specific gravity urine increased
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Speech disorder
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Musculoskeletal and connective tissue disorders
Spinal deformity
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Psychiatric disorders
Staring
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Stoma site hypergranulation
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Eye disorders
Strabismus
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Cardiac disorders
Tachycardia
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
22.2%
2/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Tonsillitis
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Tracheobronchitis
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Nervous system disorders
Tremor
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Upper respiratory tract infection
|
46.7%
7/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
40.0%
2/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
55.6%
5/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Urinary tract infection
|
26.7%
4/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
3/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Urine analysis abnormal
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Urine transitional cells present
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Use of accessory respiratory muscles
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Skin and subcutaneous tissue disorders
Vancomycin infusion reaction
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Viral infection
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Viral pharyngitis
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Viral rash
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Viral rhinitis
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
16.7%
1/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
20.0%
1/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Vitamin D decreased
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Gastrointestinal disorders
Vomiting
|
53.3%
8/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
40.0%
2/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
50.0%
3/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
88.9%
8/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Weight decreased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
2/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
33.3%
3/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
13.3%
2/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Surgical and medical procedures
Wound drainage
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
Xanthochromia
|
6.7%
1/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
|
Investigations
pH urine increased
|
0.00%
0/15 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/5 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
0.00%
0/6 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
11.1%
1/9 • From start of study drug administration up to Week 106
SAS included all participants who received at least 1 dose of SHP611 or participants who underwent the IDDD implantation procedure. As per planned analysis GLIA-MLD Matched External Control for Group A was not a part of safety analysis, so data was not collected and analyzed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place