Trial Outcomes & Findings for Safety & Tolerability Study of Chimeric Antigen Receptor T-Reg Cell Therapy in Living Donor Renal Transplant Recipients (NCT NCT04817774)
NCT ID: NCT04817774
Last Updated: 2026-07-02
Results Overview
Incidence and grade of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) according to CTCAE V5.0.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
26 participants
Primary outcome timeframe
28 days post infusion
Results posted on
2026-07-02
Participant Flow
Participants were recruited from across 5 transplant centers between March 2021 and September 2023. All 13 participants met the inclusion criteria and proceeded to the transplant.13 participants were kidney recipients. DL = dose level
There were 13 participants enrolled as well as 13 kidney donors whose completed after transplant therefore bringing the total protocol enrollment to 26.
Participant milestones
| Measure |
Treatment With TX200-TR101 (DL1)
Kidney recipient received TX200-TR101 at week 12 (DL1)
|
Treatment With TX200-TR101 (DL2)
Kidney recipient received TX200-TR101 at week 12 (DL2)
|
Treatment With TX200-TR101 (DL3)
Kidney recipient received TX200-TR101 at week 12 (DL3)
|
Treatment With TX200-TR101 (DL4)
Kidney recipient received TX200-TR101 at week 12 (DL4)
|
Controls
Kidney recipient, no study drug
|
Donors
Kidney donor. Participation completed after transplant.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
1
|
1
|
3
|
4
|
13
|
|
Overall Study
Transplant
|
4
|
1
|
1
|
3
|
4
|
13
|
|
Overall Study
Week 12
|
3
|
1
|
1
|
3
|
3
|
0
|
|
Overall Study
Week 16
|
3
|
1
|
1
|
3
|
3
|
0
|
|
Overall Study
Week 84
|
3
|
1
|
1
|
3
|
3
|
0
|
|
Overall Study
COMPLETED
|
3
|
1
|
1
|
3
|
3
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Treatment With TX200-TR101 (DL1)
Kidney recipient received TX200-TR101 at week 12 (DL1)
|
Treatment With TX200-TR101 (DL2)
Kidney recipient received TX200-TR101 at week 12 (DL2)
|
Treatment With TX200-TR101 (DL3)
Kidney recipient received TX200-TR101 at week 12 (DL3)
|
Treatment With TX200-TR101 (DL4)
Kidney recipient received TX200-TR101 at week 12 (DL4)
|
Controls
Kidney recipient, no study drug
|
Donors
Kidney donor. Participation completed after transplant.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety & Tolerability Study of Chimeric Antigen Receptor T-Reg Cell Therapy in Living Donor Renal Transplant Recipients
Baseline characteristics by cohort
| Measure |
Treatment With TX200-TR101 (DL1)
n=3 Participants
Kidney recipient received TX200-TR101 at week 12 (DL1)
|
Treatment With TX200-TR101 (DL2)
n=1 Participants
Kidney recipient received TX200-TR101 at week 12 (DL2=3xDL1)
|
Treatment With TX200-TR101 (DL3)
n=1 Participants
Kidney recipient received TX200-TR101 at week 12 (DL3=9xDL1)
|
Treatment With TX200-TR101 (DL4)
n=3 Participants
Kidney recipient received TX200-TR101 at week 12 (DL4=18xDL1)
|
Controls
n=3 Participants
Kidney recipient, no study drug.
|
Donors
n=13 Participants
Kidney donor. Participation completed after transplant.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
White
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
14 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
11 Participants
n=6 Participants
|
21 Participants
n=6 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
17 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
9 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
11 Participants
n=6 Participants
|
20 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
|
Region of Enrollment
Netherlands
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
15 Participants
n=6 Participants
|
|
Region of Enrollment
Belgium
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 28 days post infusionPopulation: Safety Analysis Set. All participants who received a kidney transplant and TX200-TR101 infusion or for controls transplant remained in the study at week 12 post-transplant.
Incidence and grade of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) according to CTCAE V5.0.
Outcome measures
| Measure |
Treatment With TX200-TR101 (DL1)
n=3 Participants
Kidney recipient received TX200-TR101 at week 12 (DL1)
|
Treatment With TX200-TR101 (DL2)
n=1 Participants
Kidney recipient received TX200-TR101 at week 12 (DL2)
|
Treatment With TX200-TR101 (DL3)
n=1 Participants
Kidney recipient received TX200-TR101 at week 12 (DL3)
|
Treatment With TX200-TR101 (DL4)
n=3 Participants
Kidney recipient received TX200-TR101 at week 12 (DL4)
|
Controls
n=3 Participants
Kidney recipient, no study drug
|
Donors
n=13 Participants
Kidney donor, participation complete at transplant.
|
|---|---|---|---|---|---|---|
|
Short Term Safety and Tolerability of TX200-TR101 Infusion.
Number of participants with TEAEs < grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Short Term Safety and Tolerability of TX200-TR101 Infusion.
Number of participants with TEAEs >= grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Short Term Safety and Tolerability of TX200-TR101 Infusion.
Number of participants with no TEAEs
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Day of infusion through to Week 84Incidence of biopsy confirmed acute rejection according to the Banff classification criteria
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day of infusion through to Week 84Number of transplant recipient subjects with TEAEs, including SAEs, as assessed by CTCAE v5.0
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day of infusion through to Week 84Ability to reduce immunosuppression as measured by the proportion of subjects receiving tacrolimus monotherapy at Week 84
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day of infusion through to Week 84Graft localization of TX200-TR101 cells as measured by the presence of CD4+ CAR+ cells in the renal transplant biopsy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day of infusion through to Week 84Chronic graft dysfunction as measured by estimated glomerular filtration rate
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day of infusion through to Week 84Incidence of chronic graft rejection according to the Banff criteria for chronic rejection
Outcome measures
Outcome data not reported
Adverse Events
Treatment With TX200-TR101 (DL1)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment With TX200-TR101 (DL2)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment With TX200-TR101 (DL3)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment With TX200-TR101 (DL4)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Controls
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Donors
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment With TX200-TR101 (DL1)
n=4 participants at risk
Kidney recipient received TX200-TR101 at week 12 (DL1)
|
Treatment With TX200-TR101 (DL2)
n=1 participants at risk
Kidney recipient received TX200-TR101 at week 12 (DL2)
|
Treatment With TX200-TR101 (DL3)
n=1 participants at risk
Kidney recipient received TX200-TR101 at week 12 (DL3)
|
Treatment With TX200-TR101 (DL4)
n=3 participants at risk
Kidney recipient received TX200-TR101 at week 12 (DL4)
|
Controls
n=4 participants at risk
Kidney recipient, no study drug
|
Donors
n=13 participants at risk
Kidney donor. Participation completed after transplant.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Infections and infestations
Pyelonephritis
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
General disorders
Malaise
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Renal and urinary disorders
Renal impairment
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Vascular disorders
Lymphocele
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Gastrointestinal disorders
Ileus
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Immune system disorders
Transplant rejection
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
Other adverse events
| Measure |
Treatment With TX200-TR101 (DL1)
n=4 participants at risk
Kidney recipient received TX200-TR101 at week 12 (DL1)
|
Treatment With TX200-TR101 (DL2)
n=1 participants at risk
Kidney recipient received TX200-TR101 at week 12 (DL2)
|
Treatment With TX200-TR101 (DL3)
n=1 participants at risk
Kidney recipient received TX200-TR101 at week 12 (DL3)
|
Treatment With TX200-TR101 (DL4)
n=3 participants at risk
Kidney recipient received TX200-TR101 at week 12 (DL4)
|
Controls
n=4 participants at risk
Kidney recipient, no study drug
|
Donors
n=13 participants at risk
Kidney donor. Participation completed after transplant.
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
50.0%
2/4 • Number of events 7 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Gastrointestinal disorders
Apthous ulcer
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Gastrointestinal disorders
Cheilitis
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Gastrointestinal disorders
Umbilical hernia
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
75.0%
3/4 • Number of events 3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Infections and infestations
COVID-19
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Infections and infestations
Fungal skin infection
|
25.0%
1/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Infections and infestations
Hepatitis E
|
25.0%
1/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Blood and lymphatic system disorders
Leukopenia
|
25.0%
1/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
50.0%
2/4 • Number of events 3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
25.0%
1/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Investigations
Hepatic enzyme increased
|
50.0%
2/4 • Number of events 3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Investigations
Donor specific antibody present
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Investigations
Blood potassium increased
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Investigations
Drug level above therapeutic
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Investigations
Glucose tolerance test abnormal
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
General disorders
Influenza like illness
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
General disorders
Malaise
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
General disorders
Catheter site pain
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
General disorders
Chills
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
General disorders
Inflammation
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
General disorders
Infusion site extravasation
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
General disorders
Non-cardiac chest pain
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Vascular disorders
Hypertension
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Vascular disorders
Lymphocele
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Nervous system disorders
Tremor
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Number of events 3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Musculoskeletal and connective tissue disorders
Myokmia
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Nervous system disorders
Paraesthesia
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Cardiac disorders
Intracardiac thrombus
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Cardiac disorders
Palpitations
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Cardiac disorders
Sinus brachycardia
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
25.0%
1/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Injury, poisoning and procedural complications
Citrate toxicity
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Renal and urinary disorders
Renal impairment
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Immune system disorders
Allergy to immunoglobulin therapy
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Immune system disorders
Cytokine release syndrome
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Eye disorders
Visual impairment
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
100.0%
1/1 • Number of events 1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/1 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/3 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/4 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
0.00%
0/13 • Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.
|
Additional Information
Medical Monitor, Sangamo Therapeutics
Sangamo Therapeutics
Phone: +1-510-307-7266
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place