Trial Outcomes & Findings for Study of Long-Term Safety and Efficacy on Gene Therapy in Glycogen Storage Disease Type Ia (NCT NCT03970278)
NCT ID: NCT03970278
Last Updated: 2026-03-18
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence, regardless of its causal relationship to study product. A TEAE is defined as any AE not present prior to the initiation of the drug treatment or any AE already present that worsens in either intensity or frequency following exposure to the drug treatment. A serious TEAE is an AE that meets any of the following criteria in the view of either the Investigator or Ultragenyx: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; disability/Incapacity; congenital anomaly/birth defect not present at screening; other important medical events. Severity of events were graded as mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4), or death (grade 5). As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
Recruitment status
COMPLETED
Target enrollment
12 participants
Primary outcome timeframe
From Baseline (Week 52 of 401GSDIA01/Visit 1 of 401GSDIA02) Up to Week 329
Results posted on
2026-03-18
Participant Flow
All 12 participants were dosed with DTX401 in study 401GSDIA01 (NCT03517085); after completing 52 weeks of follow-up in study 401GSDIA01, they subsequently enrolled in study 401GSDIA02 for an overall mean study duration of 276.2 weeks.
Participant milestones
| Measure |
DTX401 Cohort 1
Participants received a single intravenous (IV) dose of 2.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study.
No intervention: No intervention
|
DTX401 Cohort 2
Participants received a single IV dose of 6.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study.
No intervention: No intervention
|
DTX401 Cohort 3
Participants received a single IV dose of 6.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with an optimized steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study.
No intervention: No intervention
|
DTX401 Cohort 4
Participants received a single IV dose of 6.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with a prophylactic steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study.
No intervention: No intervention
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
DTX401 Cohort 1
Participants received a single intravenous (IV) dose of 2.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study.
No intervention: No intervention
|
DTX401 Cohort 2
Participants received a single IV dose of 6.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study.
No intervention: No intervention
|
DTX401 Cohort 3
Participants received a single IV dose of 6.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with an optimized steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study.
No intervention: No intervention
|
DTX401 Cohort 4
Participants received a single IV dose of 6.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with a prophylactic steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study.
No intervention: No intervention
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of Long-Term Safety and Efficacy on Gene Therapy in Glycogen Storage Disease Type Ia
Baseline characteristics by cohort
| Measure |
DTX401 Cohort 1
n=3 Participants
Participants received a single intravenous (IV) dose of 2.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study.
No intervention: No intervention
|
DTX401 Cohort 2
n=3 Participants
Participants received a single IV dose of 6.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study.
No intervention: No intervention
|
DTX401 Cohort 3
n=3 Participants
Participants received a single IV dose of 6.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with an optimized reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study.
No intervention: No intervention
|
DTX401 Cohort 4
n=3 Participants
Participants received a single IV dose of 6.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with a prophylactic steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study.
No intervention: No intervention
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=110 Participants
|
3 Participants
n=114 Participants
|
3 Participants
n=224 Participants
|
3 Participants
n=104 Participants
|
12 Participants
n=2 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 15.3 • n=110 Participants
|
29.7 years
STANDARD_DEVIATION 10.1 • n=114 Participants
|
26.0 years
STANDARD_DEVIATION 13.9 • n=224 Participants
|
25.0 years
STANDARD_DEVIATION 5.2 • n=104 Participants
|
31.5 years
STANDARD_DEVIATION 13.2 • n=2 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
2 Participants
n=224 Participants
|
1 Participants
n=104 Participants
|
4 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=110 Participants
|
3 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
2 Participants
n=104 Participants
|
8 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=110 Participants
|
1 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
1 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=110 Participants
|
2 Participants
n=114 Participants
|
3 Participants
n=224 Participants
|
3 Participants
n=104 Participants
|
11 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=110 Participants
|
3 Participants
n=114 Participants
|
3 Participants
n=224 Participants
|
3 Participants
n=104 Participants
|
12 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=110 Participants
|
0 participants
n=114 Participants
|
1 participants
n=224 Participants
|
0 participants
n=104 Participants
|
1 participants
n=2 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=110 Participants
|
0 participants
n=114 Participants
|
0 participants
n=224 Participants
|
2 participants
n=104 Participants
|
2 participants
n=2 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=110 Participants
|
3 participants
n=114 Participants
|
2 participants
n=224 Participants
|
0 participants
n=104 Participants
|
0 participants
n=2 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=110 Participants
|
0 participants
n=114 Participants
|
0 participants
n=224 Participants
|
1 participants
n=104 Participants
|
1 participants
n=2 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Week 52 of 401GSDIA01/Visit 1 of 401GSDIA02) Up to Week 329Population: Full Analysis Set: participants enrolled in Study 401GSDIA02 who received a dose of DTX401 in Study 401GSDIA01.
An adverse event (AE) is defined as any untoward medical occurrence, regardless of its causal relationship to study product. A TEAE is defined as any AE not present prior to the initiation of the drug treatment or any AE already present that worsens in either intensity or frequency following exposure to the drug treatment. A serious TEAE is an AE that meets any of the following criteria in the view of either the Investigator or Ultragenyx: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; disability/Incapacity; congenital anomaly/birth defect not present at screening; other important medical events. Severity of events were graded as mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4), or death (grade 5). As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
Outcome measures
| Measure |
DTX401 Cohort 1
n=3 Participants
Participants received a single intravenous (IV) dose of 2.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study.
No intervention: No intervention
|
DTX401 Cohort 2
n=3 Participants
Participants received a single IV dose of 6.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study.
No intervention: No intervention
|
DTX401 Cohort 3
n=3 Participants
Participants received a single IV dose of 6.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with an optimized steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study.
No intervention: No intervention
|
DTX401 Cohort 4
n=3 Participants
Participants received a single IV dose of 6.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with a prophylactic steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study.
No intervention: No intervention
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Discontinuations Due to TEAEs
TEAE
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Discontinuations Due to TEAEs
Related TEAE
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Discontinuations Due to TEAEs
Serious TEAE
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Discontinuations Due to TEAEs
Serious Related TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Discontinuations Due to TEAEs
TEAE with Maximum Severity Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Discontinuations Due to TEAEs
TEAE with Maximum Severity Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Discontinuations Due to TEAEs
TEAE with Maximum Severity Grade 3
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Discontinuations Due to TEAEs
TEAE with Maximum Severity Grade 2
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Discontinuations Due to TEAEs
TEAE with Maximum Severity Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Discontinuations Due to TEAEs
Grade 3 or 4 TEAE
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Discontinuations Due to TEAEs
Related Grade 3 or 4 TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Discontinuations Due to TEAEs
TEAE Leading to Study Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Discontinuations Due to TEAEs
TEAE Leading to Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of 401GSDIA01), Weeks 52 (Visit 1 of 401GSDIA02), 78, 104, 130, 156, 182, 208, 234, 260, Last Visit (Up to Week 329)Population: Full Analysis Set: participants enrolled in Study 401GSDIA02 who received a dose of DTX401 in Study 401GSDIA01. Participants with an assessment at given timepoint.
The change from baseline in time (in hours) to first hypoglycemic event (defined as glucose \< 54 mg/dL \[\< 3.0 mmol/L\]) during a controlled fasting challenge at the participant's last visit. A positive change from baseline is favorable. Change from baseline is calculated from Baseline (Week 0) of the 401GSDIA01 study.
Outcome measures
| Measure |
DTX401 Cohort 1
n=3 Participants
Participants received a single intravenous (IV) dose of 2.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study.
No intervention: No intervention
|
DTX401 Cohort 2
n=3 Participants
Participants received a single IV dose of 6.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study.
No intervention: No intervention
|
DTX401 Cohort 3
n=3 Participants
Participants received a single IV dose of 6.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with an optimized steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study.
No intervention: No intervention
|
DTX401 Cohort 4
n=3 Participants
Participants received a single IV dose of 6.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with a prophylactic steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study.
No intervention: No intervention
|
|---|---|---|---|---|
|
Change From Baseline in Time to First Hypoglycemic Event During a Controlled Fasting Challenge Over Time
Change at Week 52
|
4.19 hours
Standard Deviation 2.24
|
-1.78 hours
Standard Deviation 1.71
|
-0.59 hours
Standard Deviation 0.06
|
3.64 hours
Standard Deviation 2.66
|
|
Change From Baseline in Time to First Hypoglycemic Event During a Controlled Fasting Challenge Over Time
Change at Week 78
|
3.06 hours
Standard Deviation 3.96
|
-1.78 hours
Standard Deviation 1.80
|
3.21 hours
Standard Deviation 4.30
|
2.46 hours
Standard Deviation 3.53
|
|
Change From Baseline in Time to First Hypoglycemic Event During a Controlled Fasting Challenge Over Time
Change at Week 104
|
9.17 hours
Standard Deviation 1.56
|
-0.45 hours
Standard Deviation 1.93
|
4.02 hours
Standard Deviation 2.25
|
2.33 hours
Standard Deviation 3.13
|
|
Change From Baseline in Time to First Hypoglycemic Event During a Controlled Fasting Challenge Over Time
Change at Week 130
|
8.23 hours
Standard Deviation 1.91
|
0.60 hours
Standard Deviation 0.31
|
5.12 hours
Standard Deviation 3.94
|
6.33 hours
|
|
Change From Baseline in Time to First Hypoglycemic Event During a Controlled Fasting Challenge Over Time
Change at Week 156
|
9.80 hours
Standard Deviation 2.28
|
-0.22 hours
Standard Deviation 2.32
|
4.29 hours
Standard Deviation 4.06
|
5.88 hours
Standard Deviation 2.05
|
|
Change From Baseline in Time to First Hypoglycemic Event During a Controlled Fasting Challenge Over Time
Change at Week 182
|
7.91 hours
Standard Deviation 4.33
|
—
|
2.68 hours
|
—
|
|
Change From Baseline in Time to First Hypoglycemic Event During a Controlled Fasting Challenge Over Time
Change at Week 208
|
8.17 hours
Standard Deviation 3.08
|
1.46 hours
Standard Deviation 1.63
|
3.92 hours
Standard Deviation 3.51
|
2.29 hours
Standard Deviation 2.59
|
|
Change From Baseline in Time to First Hypoglycemic Event During a Controlled Fasting Challenge Over Time
Change at Week 234
|
8.41 hours
Standard Deviation 3.92
|
—
|
—
|
—
|
|
Change From Baseline in Time to First Hypoglycemic Event During a Controlled Fasting Challenge Over Time
Change at Week 260
|
8.08 hours
Standard Deviation 3.64
|
0.76 hours
Standard Deviation 0.45
|
3.58 hours
Standard Deviation 2.61
|
—
|
|
Change From Baseline in Time to First Hypoglycemic Event During a Controlled Fasting Challenge Over Time
Change at Last Visit
|
8.08 hours
Standard Deviation 3.64
|
0.76 hours
Standard Deviation 0.45
|
3.58 hours
Standard Deviation 2.61
|
2.29 hours
Standard Deviation 2.59
|
Adverse Events
DTX401 Cohort 1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
DTX401 Cohort 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
DTX401 Cohort 3
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
DTX401 Cohort 4
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DTX401 Cohort 1
n=3 participants at risk
Participants received a single intravenous (IV) dose of 2.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study
|
DTX401 Cohort 2
n=3 participants at risk
Participants received a single IV dose of 6.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study
|
DTX401 Cohort 3
n=3 participants at risk
Participants received a single IV dose of 6.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with an optimized reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study
|
DTX401 Cohort 4
n=3 participants at risk
Participants received a single IV dose of 6.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with a prophylactic steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
66.7%
2/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Covid-19
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Escherichia Infection
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Gastroenteritis Norovirus
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Injury, poisoning and procedural complications
Animal Bite
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Investigations
Blood Lactic Acid Increased
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Metabolism and nutrition disorders
Lactic Acidosis
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Nervous system disorders
Dyskinesia
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Nervous system disorders
Optic Neuritis
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Psychiatric disorders
Eating Disorder
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Renal and urinary disorders
Nephrolithiasis
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Surgical and medical procedures
Preoperative Care
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Vascular disorders
Hypertensive Urgency
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
Other adverse events
| Measure |
DTX401 Cohort 1
n=3 participants at risk
Participants received a single intravenous (IV) dose of 2.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study
|
DTX401 Cohort 2
n=3 participants at risk
Participants received a single IV dose of 6.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study
|
DTX401 Cohort 3
n=3 participants at risk
Participants received a single IV dose of 6.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with an optimized reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study
|
DTX401 Cohort 4
n=3 participants at risk
Participants received a single IV dose of 6.0 × 10\^12 GC/kg DTX401(pariglasgene brecaparvovec) with a prophylactic steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Blood and lymphatic system disorders
Nephrogenic Anaemia
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Cardiac disorders
Cardiac Flutter
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Cardiac disorders
Palpitations
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Congenital, familial and genetic disorders
Glycogen Storage Disorder
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Ear and labyrinth disorders
Vertigo
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Gastrointestinal disorders
Abdominal Pain
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Gastrointestinal disorders
Pelvic Floor Dysfunction
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Gastrointestinal disorders
Toothache
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
66.7%
2/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
General disorders
Asthenia
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
General disorders
Catheter Site Discharge
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
General disorders
Chills
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
General disorders
Fatigue
|
66.7%
2/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
General disorders
Infusion Site Extravasation
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Hepatobiliary disorders
Hepatic Mass
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Immune system disorders
Food Allergy
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Corneal Infection
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Covid-19
|
66.7%
2/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
66.7%
2/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
100.0%
3/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
66.7%
2/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Diarrhoea Infectious
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Epididymitis
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Gastritis Viral
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Gastrointestinal Infection
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Gastrointestinal Viral Infection
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Injury, poisoning and procedural complications
Animal Bite
|
66.7%
2/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Injury, poisoning and procedural complications
Contusion
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Injury, poisoning and procedural complications
Corneal Abrasion
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Injury, poisoning and procedural complications
Nail Injury
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Injury, poisoning and procedural complications
Post Procedural Fistula
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Injury, poisoning and procedural complications
Stoma Site Irritation
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Injury, poisoning and procedural complications
Vaccination Complication
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Investigations
Albumin Urine Present
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Investigations
Blood Glucose Fluctuation
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Investigations
Blood Lactic Acid Increased
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Investigations
Glomerular Filtration Rate Increased
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Investigations
Haematocrit Increased
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Investigations
Neutrophil Count Increased
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Investigations
Platelet Count Increased
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Investigations
Prothrombin Time Prolonged
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Investigations
Sars-Cov-2 Test Positive
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Investigations
Transaminases Increased
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Investigations
Weight Decreased
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
66.7%
2/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
66.7%
2/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
66.7%
2/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
66.7%
2/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
66.7%
2/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.7%
2/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma Of Liver
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Nervous system disorders
Hypoaesthesia
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Nervous system disorders
Migraine
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Nervous system disorders
Sensory Disturbance
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Psychiatric disorders
Depression
|
66.7%
2/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Psychiatric disorders
Drug Abuse
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Psychiatric disorders
Mood Swings
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Renal and urinary disorders
Nephrolithiasis
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Renal and urinary disorders
Nephropathy
|
66.7%
2/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Symptom
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Skin and subcutaneous tissue disorders
Skin Fissures
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Vascular disorders
Arteriosclerosis
|
33.3%
1/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
|
Vascular disorders
Hypertension
|
66.7%
2/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
66.7%
2/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
0.00%
0/3 • All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60