Trial Outcomes & Findings for Safety and Dose-Finding Study of DTX301 (scAAV8OTC) in Adults With Late-Onset Ornithine Transcarbamylase (OTC) Deficiency (NCT NCT02991144)
NCT ID: NCT02991144
Last Updated: 2023-01-26
Results Overview
AE: any untoward medical occurrence regardless of its causal relationship to study product. TEAE: any event not present before exposure to study product or any event already present that worsens in either intensity or frequency after exposure to study product. SAE: any event that results in death; is immediately life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is an important medical event, according to the investigator. AE intensity was rated as Grade 1 (mild), 2 (moderate), 3 (severe), 4 (life threatening), or 5 (death) according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). The relationship or association of the study product in causing or contributing to the AE was characterized as: unrelated; possible; probably; definite.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
16 participants
Primary outcome timeframe
AEs Prior to Dosing: From signing the informed consent form (ICF) to first dose of study drug. TEAEs: From first dose of study drug up to End of Study (Week 52).
Results posted on
2023-01-26
Participant Flow
A total of 27 subjects were screened for the study, 16 of whom were enrolled. Of the 16 participants enrolled, 5 participants discontinued the study before receiving DTX301, and were not assigned to a treatment arm.
Participant milestones
| Measure |
Cohort 1: DTX301 2.0 × 10^12 GC/kg
DTX301 (scAAV8OTC) 2.0 × 10\^12 GC/kg administered as a single peripheral intravenous (IV) infusion.
|
Cohort 2: DTX301 6.0 × 10^12 GC/kg
DTX301 (scAAV8OTC) 6.0 × 10\^12 GC/kg administered as a single peripheral IV infusion.
|
Cohort 3: DTX301 1.0 × 10^13 GC/kg
DTX301 (scAAV8OTC) 1.0 × 10\^13 GC/kg administered as a single peripheral IV infusion.
|
Cohort 4: DTX301 1.0x10^13 GC/kg + Prophylactic Corticosteroids
Oral prednisone (or prednisolone), 60 mg tapered over 9 weeks, initiated before dosing with DTX301 (scAAV8OTC) and administered through Week 4. DTX301 (scAAV8OTC) 1.0x10\^13 GC/kg administered as a single peripheral IV infusion.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
participants with a baseline assessment
Baseline characteristics by cohort
| Measure |
Cohort 1: DTX301 2.0 × 10^12 GC/kg
n=3 Participants
DTX301 (scAAV8OTC) 2.0 × 10\^12 GC/kg administered as a single peripheral IV infusion.
|
Cohort 2: DTX301 6.0 × 10^12 GC/kg
n=3 Participants
DTX301 (scAAV8OTC) 6.0 × 10\^12 GC/kg administered as a single peripheral IV infusion.
|
Cohort 3: DTX301 1.0 × 10^13 GC/kg
n=3 Participants
DTX301 (scAAV8OTC) 1.0 × 10\^13 GC/kg administered as a single peripheral IV infusion.
|
Cohort 4: DTX301 1.0x10^13 GC/kg + Prophylactic Corticosteroids
n=2 Participants
Oral prednisone (or prednisolone), 60 mg tapered over 9 weeks, initiated before dosing with DTX301 (scAAV8OTC) and administered through Week 4. DTX301 (scAAV8OTC) 1.0x10\^13 GC/kg administered as a single peripheral IV infusion.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.3 years
STANDARD_DEVIATION 11.06 • n=3 Participants
|
27.7 years
STANDARD_DEVIATION 1.15 • n=3 Participants
|
26.7 years
STANDARD_DEVIATION 7.09 • n=3 Participants
|
30.5 years
STANDARD_DEVIATION 13.44 • n=2 Participants
|
29.2 years
STANDARD_DEVIATION 7.67 • n=11 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
7 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
4 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
10 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
10 Participants
n=11 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=11 Participants
|
|
Rate of Ureagenesis
|
166.293 μmol*h/kg
STANDARD_DEVIATION 28.0167 • n=3 Participants
|
103.329 μmol*h/kg
STANDARD_DEVIATION 76.9798 • n=3 Participants
|
115.492 μmol*h/kg
STANDARD_DEVIATION 71.0753 • n=3 Participants
|
174.678 μmol*h/kg
STANDARD_DEVIATION 210.9140 • n=2 Participants
|
136.791 μmol*h/kg
STANDARD_DEVIATION 88.4373 • n=11 Participants
|
|
Area Under the Curve From Time Zero to 24 Hours (AUC0 24) of Plasma Ammonia
|
1831.78 μmol*h/L
STANDARD_DEVIATION 1445.240 • n=3 Participants • participants with a baseline assessment
|
2153.74 μmol*h/L
STANDARD_DEVIATION 1406.173 • n=3 Participants • participants with a baseline assessment
|
4444.76 μmol*h/L
STANDARD_DEVIATION NA • n=1 Participants • participants with a baseline assessment
|
1834.39 μmol*h/L
STANDARD_DEVIATION 1091.019 • n=2 Participants • participants with a baseline assessment
|
2230.01 μmol*h/L
STANDARD_DEVIATION 1370.847 • n=9 Participants • participants with a baseline assessment
|
PRIMARY outcome
Timeframe: AEs Prior to Dosing: From signing the informed consent form (ICF) to first dose of study drug. TEAEs: From first dose of study drug up to End of Study (Week 52).Population: Safety Set: all participants who received DTX301.
AE: any untoward medical occurrence regardless of its causal relationship to study product. TEAE: any event not present before exposure to study product or any event already present that worsens in either intensity or frequency after exposure to study product. SAE: any event that results in death; is immediately life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is an important medical event, according to the investigator. AE intensity was rated as Grade 1 (mild), 2 (moderate), 3 (severe), 4 (life threatening), or 5 (death) according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). The relationship or association of the study product in causing or contributing to the AE was characterized as: unrelated; possible; probably; definite.
Outcome measures
| Measure |
Cohort 1: DTX301 2.0 × 10^12 GC/kg
n=3 Participants
DTX301 (scAAV8OTC) 2.0 × 10\^12 GC/kg administered as a single peripheral IV infusion.
|
Cohort 2: DTX301 6.0 × 10^12 GC/kg
n=3 Participants
DTX301 (scAAV8OTC) 6.0 × 10\^12 GC/kg administered as a single peripheral IV infusion.
|
Cohort 3: DTX301 1.0 × 10^13 GC/kg
n=3 Participants
DTX301 (scAAV8OTC) 1.0 × 10\^13 GC/kg administered as a single peripheral IV infusion.
|
Cohort 4: DTX301 1.0x10^13 GC/kg + Prophylactic Corticosteroids
n=2 Participants
Oral prednisone (or prednisolone), 60 mg tapered over 9 weeks, initiated before dosing with DTX301 (scAAV8OTC) and administered through Week 4. DTX301 (scAAV8OTC) 1.0x10\^13 GC/kg administered as a single peripheral IV infusion.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and TEAEs Leading to Discontinuation
Any TEAE
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and TEAEs Leading to Discontinuation
Any serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and TEAEs Leading to Discontinuation
Any TEAE with grade >=3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and TEAEs Leading to Discontinuation
Any study drug-related TEAE
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and TEAEs Leading to Discontinuation
Any hyperammonemic crisis-related TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and TEAEs Leading to Discontinuation
Any TEAE leading to study discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and TEAEs Leading to Discontinuation
Any adverse event leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and TEAEs Leading to Discontinuation
Any AE prior to dosing
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and TEAEs Leading to Discontinuation
Any TEAE related to corticosteroid regimen
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and TEAEs Leading to Discontinuation
Any study drug-related serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and TEAEs Leading to Discontinuation
Any study drug-related TEAE with grade >=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Weeks 6, 12, 20, 24, End of Study (Week 52). AUC was derived based on the following time points: 0.5, 1, 1.5, 2, 3, and 4 hours postdose.Population: Safety Set: all participants who received DTX301.
The change from baseline in the rate of ureagenesis (as measured by the generation of \[13C\]urea over 4 hours) as determined by gas chromatography mass spectrometry over time to 52 weeks after the IV administration of DTX301. Sodium acetate was used as a tracer to measure the rate of ureagenesis. Rate of ureagenesis was derived in the following manner: 1. Derive area under the curve from time zero to 240 minutes (AUC0-240min) of absolute 13C-urea (µmol/l/min) estimated by the linear trapezoidal rule 2. Derive percent of normal AUC0-240min of absolute 13C-urea by dividing AUC0-240min of absolute 13C-urea (µmol\*min/L) by 669.56 µmol\*min/L (i.e. the AUC0-240min of absolute 13C-urea for an adult control) 3. Derive rate of ureagenesis by multiplying % of normal AUC0-240min of absolute 13C-urea by 300 µmol\*h/kg (i.e. the approximate rate of ureagenesis in healthy adults).
Outcome measures
| Measure |
Cohort 1: DTX301 2.0 × 10^12 GC/kg
n=3 Participants
DTX301 (scAAV8OTC) 2.0 × 10\^12 GC/kg administered as a single peripheral IV infusion.
|
Cohort 2: DTX301 6.0 × 10^12 GC/kg
n=3 Participants
DTX301 (scAAV8OTC) 6.0 × 10\^12 GC/kg administered as a single peripheral IV infusion.
|
Cohort 3: DTX301 1.0 × 10^13 GC/kg
n=3 Participants
DTX301 (scAAV8OTC) 1.0 × 10\^13 GC/kg administered as a single peripheral IV infusion.
|
Cohort 4: DTX301 1.0x10^13 GC/kg + Prophylactic Corticosteroids
n=2 Participants
Oral prednisone (or prednisolone), 60 mg tapered over 9 weeks, initiated before dosing with DTX301 (scAAV8OTC) and administered through Week 4. DTX301 (scAAV8OTC) 1.0x10\^13 GC/kg administered as a single peripheral IV infusion.
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Rate of Ureagenesis
Change at Week 12
|
2.363 μmol*h/kg
Standard Deviation 51.2516
|
20.897 μmol*h/kg
Standard Deviation 56.9733
|
7.544 μmol*h/kg
Standard Deviation 133.1715
|
65.781 μmol*h/kg
Standard Deviation 33.9137
|
|
Change From Baseline Over Time in Rate of Ureagenesis
Change at End of Study (Week 52)
|
109.611 μmol*h/kg
Standard Deviation 171.0689
|
114.446 μmol*h/kg
Standard Deviation 98.8701
|
10.016 μmol*h/kg
Standard Deviation 47.9128
|
128.023 μmol*h/kg
Standard Deviation 131.6469
|
|
Change From Baseline Over Time in Rate of Ureagenesis
Change at Week 6
|
41.139 μmol*h/kg
Standard Deviation 83.3604
|
46.857 μmol*h/kg
Standard Deviation 105.9147
|
-29.017 μmol*h/kg
Standard Deviation 127.2471
|
14.586 μmol*h/kg
Standard Deviation 17.3499
|
|
Change From Baseline Over Time in Rate of Ureagenesis
Change at Week 20
|
32.929 μmol*h/kg
Standard Deviation 71.0500
|
77.465 μmol*h/kg
Standard Deviation 67.1567
|
-0.194 μmol*h/kg
Standard Deviation 112.5922
|
67.103 μmol*h/kg
Standard Deviation 102.5409
|
|
Change From Baseline Over Time in Rate of Ureagenesis
Change at Week 24
|
42.540 μmol*h/kg
Standard Deviation 136.5861
|
65.513 μmol*h/kg
Standard Deviation 50.5169
|
45.114 μmol*h/kg
Standard Deviation 147.5760
|
63.854 μmol*h/kg
Standard Deviation 106.7694
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Weeks 6, 12, 24, End of Study (Week 52). AUC was derived based on predose (time 0) and approximately 2, 4, 8, 12, 16, 20, 24 hours (±5 minutes) postdose.Population: Safety Set: all participants who received DTX301. Participants with an assessment at given time point.
Outcome measures
| Measure |
Cohort 1: DTX301 2.0 × 10^12 GC/kg
n=3 Participants
DTX301 (scAAV8OTC) 2.0 × 10\^12 GC/kg administered as a single peripheral IV infusion.
|
Cohort 2: DTX301 6.0 × 10^12 GC/kg
n=3 Participants
DTX301 (scAAV8OTC) 6.0 × 10\^12 GC/kg administered as a single peripheral IV infusion.
|
Cohort 3: DTX301 1.0 × 10^13 GC/kg
n=3 Participants
DTX301 (scAAV8OTC) 1.0 × 10\^13 GC/kg administered as a single peripheral IV infusion.
|
Cohort 4: DTX301 1.0x10^13 GC/kg + Prophylactic Corticosteroids
n=2 Participants
Oral prednisone (or prednisolone), 60 mg tapered over 9 weeks, initiated before dosing with DTX301 (scAAV8OTC) and administered through Week 4. DTX301 (scAAV8OTC) 1.0x10\^13 GC/kg administered as a single peripheral IV infusion.
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Area Under the Curve From Time Zero to 24 Hours (AUC0-24) of Plasma Ammonia
Change at Week 24
|
-252.54 μmol*h/L
Standard Deviation 586.131
|
-1065.48 μmol*h/L
Standard Deviation 1024.167
|
-3978.51 μmol*h/L
Standard Deviation NA
1 participant analyzed
|
-1276.25 μmol*h/L
Standard Deviation 943.999
|
|
Change From Baseline Over Time in Area Under the Curve From Time Zero to 24 Hours (AUC0-24) of Plasma Ammonia
Change at End of Study (Week 52)
|
-381.54 μmol*h/L
Standard Deviation 1116.898
|
-387.02 μmol*h/L
Standard Deviation 277.086
|
-594.76 μmol*h/L
Standard Deviation NA
1 participant analyzed
|
-359.17 μmol*h/L
Standard Deviation 1641.519
|
|
Change From Baseline Over Time in Area Under the Curve From Time Zero to 24 Hours (AUC0-24) of Plasma Ammonia
Change at Week 6
|
97.69 μmol*h/L
Standard Deviation 104.381
|
-1334.27 μmol*h/L
Standard Deviation 1271.205
|
-3790.83 μmol*h/L
Standard Deviation NA
1 participant analyzed
|
-1095.20 μmol*h/L
Standard Deviation 785.719
|
|
Change From Baseline Over Time in Area Under the Curve From Time Zero to 24 Hours (AUC0-24) of Plasma Ammonia
Change at Week 12
|
-264.07 μmol*h/L
Standard Deviation 1471.172
|
-1384.95 μmol*h/L
Standard Deviation 1279.839
|
-3827.36 μmol*h/L
Standard Deviation NA
1 participant analyzed
|
-1242.69 μmol*h/L
Standard Deviation 931.242
|
Adverse Events
DTX301 2.0 × 10^12 GC/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
DTX301 6.0 × 10^12 GC/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
DTX301 1.0 × 10^13 GC/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
DTX301 1.0x10^13 GC/kg + Prophylactic Corticosteroids
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Total
Serious events: 1 serious events
Other events: 11 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
DTX301 2.0 × 10^12 GC/kg
n=3 participants at risk
DTX301 (scAAV8OTC) 2.0 × 10\^12 GC/kg administered as a single peripheral IV infusion.
|
DTX301 6.0 × 10^12 GC/kg
n=3 participants at risk
DTX301 (scAAV8OTC) 6.0 × 10\^12 GC/kg administered as a single peripheral IV infusion.
|
DTX301 1.0 × 10^13 GC/kg
n=3 participants at risk
DTX301 (scAAV8OTC) 1.0 × 10\^13 GC/kg administered as a single peripheral IV infusion.
|
DTX301 1.0x10^13 GC/kg + Prophylactic Corticosteroids
n=2 participants at risk
Oral prednisone (or prednisolone), 60 mg tapered over 9 weeks, initiated before dosing with DTX301 (scAAV8OTC) and administered through Week 4. DTX301 (scAAV8OTC) 1.0x10\^13 GC/kg administered as a single peripheral IV infusion.
|
Total
n=11 participants at risk
All Participants
|
|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperammonaemic Crisis
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
50.0%
1/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
Other adverse events
| Measure |
DTX301 2.0 × 10^12 GC/kg
n=3 participants at risk
DTX301 (scAAV8OTC) 2.0 × 10\^12 GC/kg administered as a single peripheral IV infusion.
|
DTX301 6.0 × 10^12 GC/kg
n=3 participants at risk
DTX301 (scAAV8OTC) 6.0 × 10\^12 GC/kg administered as a single peripheral IV infusion.
|
DTX301 1.0 × 10^13 GC/kg
n=3 participants at risk
DTX301 (scAAV8OTC) 1.0 × 10\^13 GC/kg administered as a single peripheral IV infusion.
|
DTX301 1.0x10^13 GC/kg + Prophylactic Corticosteroids
n=2 participants at risk
Oral prednisone (or prednisolone), 60 mg tapered over 9 weeks, initiated before dosing with DTX301 (scAAV8OTC) and administered through Week 4. DTX301 (scAAV8OTC) 1.0x10\^13 GC/kg administered as a single peripheral IV infusion.
|
Total
n=11 participants at risk
All Participants
|
|---|---|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
50.0%
1/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
18.2%
2/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
50.0%
1/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Endocrine disorders
Cushingoid
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
18.2%
2/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Eye disorders
Photophobia
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
50.0%
1/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
50.0%
1/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
50.0%
1/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
50.0%
1/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
18.2%
2/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
General disorders
Catheter Site Pain
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
General disorders
Fatigue
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
18.2%
2/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
General disorders
Feeling Abnormal
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
50.0%
1/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
18.2%
2/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
General disorders
Feeling Jittery
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
50.0%
1/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
General disorders
Gait Disturbance
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Hepatobiliary disorders
Gallbladder Polyp
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
50.0%
1/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
18.2%
2/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
50.0%
1/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Injury, poisoning and procedural complications
Exposure To Sars-Cov-2
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
100.0%
2/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
18.2%
2/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Investigations
Hepatic Enzyme Increased
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
18.2%
2/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Investigations
Liver Function Test Increased
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
100.0%
2/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
18.2%
2/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
50.0%
1/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
50.0%
1/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
50.0%
1/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
50.0%
1/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
66.7%
2/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
100.0%
2/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
45.5%
5/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
50.0%
1/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
50.0%
1/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Nervous system disorders
Somnolence
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
50.0%
1/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
18.2%
2/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Psychiatric disorders
Claustrophobia
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Psychiatric disorders
Phonophobia
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
50.0%
1/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
18.2%
2/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-Airway Cough Syndrome
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
50.0%
1/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
9.1%
1/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
0.00%
0/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
33.3%
1/3 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
50.0%
1/2 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
27.3%
3/11 • All Cause Mortality: from screening up to End of Study (Week 52). Adverse Events and Serious Adverse Events: From first dose of study drug up to End of Study (Week 52).
2 enrolled participants died before receiving DTX301, and were not assigned to a treatment arm. These participants are reflected in the 'total' column of the all-cause mortality table.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER