Trial Outcomes & Findings for Safety & Efficacy of Encapsulated Allogeneic FVIII Cell Therapy in Haemophilia A (NCT NCT04541628)
NCT ID: NCT04541628
Last Updated: 2024-09-04
Results Overview
Number of Participants with at least one TEAEs are reported. A summary of other nonserious adverse events (AEs), and all serious adverse events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
3 participants
Primary outcome timeframe
Baseline Up to 115 Weeks
Results posted on
2024-09-04
Participant Flow
Participant milestones
| Measure |
Cohort 1
Participants received a single dose of 50 milliliter (mL) SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce B-Domain Deleted Human Factor VIII (BDD-hFVIII) producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 2
Participants received a single dose of 78.5 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 3
Participants received a single dose of 133 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
|
Overall Study
Received at Least One Dose of Study Drug
|
1
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1
Participants received a single dose of 50 milliliter (mL) SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce B-Domain Deleted Human Factor VIII (BDD-hFVIII) producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 2
Participants received a single dose of 78.5 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 3
Participants received a single dose of 133 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
|---|---|---|---|
|
Overall Study
Study Terminated
|
1
|
1
|
1
|
Baseline Characteristics
Safety & Efficacy of Encapsulated Allogeneic FVIII Cell Therapy in Haemophilia A
Baseline characteristics by cohort
| Measure |
Cohort 1
n=1 Participants
Participants received a single dose of 50 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce B-Domain Deleted Human Factor VIII (BDD-hFVIII) producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 2
n=1 Participants
Participants received a single dose of 78.5 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 3
n=1 Participants
Participants received a single dose of 133 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline Up to 115 WeeksPopulation: All participants who received at least one dose of study drug and have at least one postdose safety assessment.
Number of Participants with at least one TEAEs are reported. A summary of other nonserious adverse events (AEs), and all serious adverse events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
Cohort 1
n=1 Participants
Participants received a single dose of 50 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce B-Domain Deleted Human Factor VIII (BDD-hFVIII) producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 2
n=1 Participants
Participants received a single dose of 78.5 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 3
n=1 Participants
Participants received a single dose of 133 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
1 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline Up to 115 WeeksPopulation: All participants who received at least one dose of study drug and have at least one postdose safety assessment.
Number of Participants with at least one serious TEAEs are reported. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
Cohort 1
n=1 Participants
Participants received a single dose of 50 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce B-Domain Deleted Human Factor VIII (BDD-hFVIII) producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 2
n=1 Participants
Participants received a single dose of 78.5 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 3
n=1 Participants
Participants received a single dose of 133 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
|---|---|---|---|
|
Number of Participants With Serious Treatment Emergent Adverse Events (TEAEs)
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline Up to 115 WeeksPopulation: All participants who received at least one dose of study drug and had at least one postbaseline efficacy assessment.
Development of FVIII inhibitors is measured using the Nijmegen Bethesda inhibitor assay. The assay measures inhibitors to BDD-FVIII and also other forms of FVIII in the plasma, although rFVIII-BDD was used as a calibrator.
Outcome measures
| Measure |
Cohort 1
n=1 Participants
Participants received a single dose of 50 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce B-Domain Deleted Human Factor VIII (BDD-hFVIII) producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 2
n=1 Participants
Participants received a single dose of 78.5 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 3
n=1 Participants
Participants received a single dose of 133 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
|---|---|---|---|
|
Number of Participants With Inhibitor Titer Values Assessed by Nijmegen Bethesda Assay
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline Up to 115 WeeksPopulation: All participants who received at least one dose of study drug and had at least one postbaseline efficacy assessment.
The change from baseline in FVIII activity, as measured by one-stage and chromogenic assays) is summarized.
Outcome measures
| Measure |
Cohort 1
n=1 Participants
Participants received a single dose of 50 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce B-Domain Deleted Human Factor VIII (BDD-hFVIII) producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 2
n=1 Participants
Participants received a single dose of 78.5 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 3
n=1 Participants
Participants received a single dose of 133 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
|---|---|---|---|
|
Change From Baseline in FVIII Activity Levels Assessed by One-stage and Chromogenic Assays
Chromogenic Assay
|
13.03 International Unit/deciliter (IU/dL)
Standard Deviation NA
The number of participants is 1, so the Standard Deviation was not calculated.
|
223.78 International Unit/deciliter (IU/dL)
Standard Deviation NA
The number of participants is 1, so the Standard Deviation was not calculated.
|
-122.71 International Unit/deciliter (IU/dL)
Standard Deviation NA
The number of participants is 1, so the Standard Deviation was not calculated.
|
|
Change From Baseline in FVIII Activity Levels Assessed by One-stage and Chromogenic Assays
One-stage
|
15.46 International Unit/deciliter (IU/dL)
Standard Deviation NA
The number of participants is 1, so the Standard Deviation was not calculated.
|
118.28 International Unit/deciliter (IU/dL)
Standard Deviation NA
The number of participants is 1, so the Standard Deviation was not calculated.
|
189.63 International Unit/deciliter (IU/dL)
Standard Deviation NA
The number of participants is 1, so the Standard Deviation was not calculated.
|
SECONDARY outcome
Timeframe: Time Frame: Pre-infusion (bleeding events in 12 months prior to sphere placement), 1 year, 2 year and 3-year post-infusion (post sphere placement) from SIG-001 administration annualized up to 115 Weeks.Population: All participants who received at least one dose of study drug and had at least one postbaseline efficacy assessment.
The annualized number of bleeds per participant (annualized bleeding rate) is calculated as the number of bleeding events divided by length of time on study product follow-up, in years. The duration of assessment for this outcome measure was two years and three months, and Year 3 includes only the three-month part of this study period.
Outcome measures
| Measure |
Cohort 1
n=1 Participants
Participants received a single dose of 50 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce B-Domain Deleted Human Factor VIII (BDD-hFVIII) producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 2
n=1 Participants
Participants received a single dose of 78.5 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 3
n=1 Participants
Participants received a single dose of 133 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
|---|---|---|---|
|
Number of Bleeding Events [Annualized Bleeding Rate (ABR)] for All Bleeds Following SIG-001 Administration
Year 1
|
7 Bleeding events per year
|
1 Bleeding events per year
|
10 Bleeding events per year
|
|
Number of Bleeding Events [Annualized Bleeding Rate (ABR)] for All Bleeds Following SIG-001 Administration
Year 2
|
5 Bleeding events per year
|
0 Bleeding events per year
|
0 Bleeding events per year
|
|
Number of Bleeding Events [Annualized Bleeding Rate (ABR)] for All Bleeds Following SIG-001 Administration
Year 3
|
0 Bleeding events per year
|
0 Bleeding events per year
|
NA Bleeding events per year
Data not available as participant left the study before year 3
|
|
Number of Bleeding Events [Annualized Bleeding Rate (ABR)] for All Bleeds Following SIG-001 Administration
Pre-infusion
|
4 Bleeding events per year
|
0 Bleeding events per year
|
4 Bleeding events per year
|
SECONDARY outcome
Timeframe: Baseline Up to 115 weeksPopulation: All participants who received at least one dose of study drug and had at least one postbaseline efficacy assessment.
Number of doses after prophylaxis discontinued is reported.
Outcome measures
| Measure |
Cohort 1
n=1 Participants
Participants received a single dose of 50 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce B-Domain Deleted Human Factor VIII (BDD-hFVIII) producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 2
n=1 Participants
Participants received a single dose of 78.5 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 3
n=1 Participants
Participants received a single dose of 133 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
|---|---|---|---|
|
Total Number of Replacement FVIII Therapies
|
401 Number of doses
|
327 Number of doses
|
1558 Number of doses
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=1 participants at risk
Participants received a single dose of 50 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce B-Domain Deleted Human Factor VIII (BDD-hFVIII) producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 2
n=1 participants at risk
Participants received a single dose of 78.5 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 3
n=1 participants at risk
Participants received a single dose of 133 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Factor viii inhibition
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Drug ineffective
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Anti factor viii antibody increased
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Cohort 1
n=1 participants at risk
Participants received a single dose of 50 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce B-Domain Deleted Human Factor VIII (BDD-hFVIII) producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 2
n=1 participants at risk
Participants received a single dose of 78.5 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
Cohort 3
n=1 participants at risk
Participants received a single dose of 133 mL SIG-001 spheres \[an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII producing Spheres\] administered laparoscopically into the peritoneal cavity.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 4 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 3 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Axillary pain
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 3 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Vaccination site pain
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Covid-19
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 3 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 2 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 2 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Cullen's sign
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Umbilical erythema
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 115 Weeks
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60