Trial Outcomes & Findings for Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism (NCT NCT02923115)
NCT ID: NCT02923115
Last Updated: 2023-04-19
Results Overview
Clinically relevant bleeding was defined as major or clinically relevant non-major (CRNM) bleeding adjudicated by the Clinical Events Committee (CEC) based on International Society of Thrombosis and Haemostasis (ISTH) definitions and the CEC charter.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
134 participants
Primary outcome timeframe
Baseline up to Day 30 post infusion, up to approximately 3 years 2 months
Results posted on
2023-04-19
Participant Flow
A total of 134 participants who met all inclusion and no exclusion criteria were enrolled in the study at 47 clinic sites (15 in the United States and 32 in Europe). Of the 134 participants randomized to treatment, 125 received treatment.
This study enrolled up to 5 sequential, ascending-dose, continuous infusion cohorts (starting DS1040b dose 20 mg). In Cohorts 1 and 2, eligible participants were randomized in a 2:1 ratio to either DS-1040b or placebo. Starting with Cohort 3, the ratio changed to 3:1. All participants received standard of care enoxaparin during study drug infusion.
Participant milestones
| Measure |
Cohort 1: DS-1040b 20 mg
Participants who received an intravenous infusion of 20 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 2: DS-1040b 40 mg
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 3: DS-1040b 60 mg
Participants who received an intravenous infusion of 60 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 4: DS-1040b 80 mg
Participants who received an intravenous infusion of 80 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 5: DS-1040b 40 mg
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Placebo
Participants who received an intravenous infusion of placebo in addition to standard of care anticoagulation therapy.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
16
|
23
|
23
|
22
|
38
|
|
Overall Study
Treated
|
12
|
16
|
20
|
22
|
17
|
38
|
|
Overall Study
COMPLETED
|
12
|
15
|
20
|
21
|
17
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
3
|
2
|
5
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: DS-1040b 20 mg
Participants who received an intravenous infusion of 20 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 2: DS-1040b 40 mg
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 3: DS-1040b 60 mg
Participants who received an intravenous infusion of 60 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 4: DS-1040b 80 mg
Participants who received an intravenous infusion of 80 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 5: DS-1040b 40 mg
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Placebo
Participants who received an intravenous infusion of placebo in addition to standard of care anticoagulation therapy.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Randomized, but not dosed
|
0
|
0
|
3
|
1
|
5
|
0
|
Baseline Characteristics
Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism
Baseline characteristics by cohort
| Measure |
Cohort 1: DS-1040b 20 mg
n=12 Participants
Participants who received an intravenous infusion of 20 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 2: DS-1040b 40 mg
n=16 Participants
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 3: DS-1040b 60 mg
n=20 Participants
Participants who received an intravenous infusion of 60 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 4: DS-1040b 80 mg
n=22 Participants
Participants who received an intravenous infusion of 80 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 5: DS-1040b 40 mg
n=17 Participants
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Placebo
n=38 Participants
Participants who received an intravenous infusion of placebo in addition to standard of care anticoagulation therapy.
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
79 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
46 Participants
n=115 Participants
|
|
Age, Continuous
|
56.1 years
STANDARD_DEVIATION 16.3 • n=5 Participants
|
62.1 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
55.1 years
STANDARD_DEVIATION 17.5 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 13.5 • n=4 Participants
|
56.5 years
STANDARD_DEVIATION 9.8 • n=21 Participants
|
58.3 years
STANDARD_DEVIATION 10.7 • n=10 Participants
|
57.2 years
STANDARD_DEVIATION 13.0 • n=115 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
40 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
85 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
118 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 30 post infusion, up to approximately 3 years 2 monthsPopulation: Adjudicated bleeding events were assessed in the Safety Analysis Set.
Clinically relevant bleeding was defined as major or clinically relevant non-major (CRNM) bleeding adjudicated by the Clinical Events Committee (CEC) based on International Society of Thrombosis and Haemostasis (ISTH) definitions and the CEC charter.
Outcome measures
| Measure |
Cohort 4: DS-1040b 80 mg
n=22 Participants
Participants who received an intravenous infusion of 80 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 5: DS-1040b 40 mg
n=17 Participants
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Placebo
n=38 Participants
Participants who received an intravenous infusion of placebo in addition to standard of care anticoagulation therapy.
|
Cohort 1: DS-1040b 20 mg
n=12 Participants
Participants who received an intravenous infusion of 20 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 2: DS-1040b 40 mg
n=16 Participants
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 3: DS-1040b 60 mg
n=20 Participants
Participants who received an intravenous infusion of 60 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Adjudicated Clinically Relevant Bleeding Events Following Intravenous Infusion of DS-1040b or Placebo in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism
At least 1 bleeding event
|
4 Participants
|
1 Participants
|
10 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants Experiencing Adjudicated Clinically Relevant Bleeding Events Following Intravenous Infusion of DS-1040b or Placebo in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism
Major bleeding event
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Adjudicated Clinically Relevant Bleeding Events Following Intravenous Infusion of DS-1040b or Placebo in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism
Non-major clinically relevant bleeding event
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Adjudicated Clinically Relevant Bleeding Events Following Intravenous Infusion of DS-1040b or Placebo in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism
Minor or nuisance bleeding event
|
2 Participants
|
0 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants Experiencing Adjudicated Clinically Relevant Bleeding Events Following Intravenous Infusion of DS-1040b or Placebo in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism
Fatal bleeding event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Adjudicated Clinically Relevant Bleeding Events Following Intravenous Infusion of DS-1040b or Placebo in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism
Bleeding with Hb drop ≥2g/dL, transfusion ≥2 units
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to 12-72 hours post start of infusion, up to approximately 3 years 2 monthsPopulation: Changes in total thrombus volume were assessed in the Efficacy Analysis Set.
The change from baseline in total thrombus volume was assessed by computed tomography angiography in segmental or larger pulmonary arteries following intravenous infusion of DS-1040b or placebo in addition to standard of care anti-coagulation therapy.
Outcome measures
| Measure |
Cohort 4: DS-1040b 80 mg
n=22 Participants
Participants who received an intravenous infusion of 80 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 5: DS-1040b 40 mg
n=16 Participants
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Placebo
n=36 Participants
Participants who received an intravenous infusion of placebo in addition to standard of care anticoagulation therapy.
|
Cohort 1: DS-1040b 20 mg
n=11 Participants
Participants who received an intravenous infusion of 20 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 2: DS-1040b 40 mg
n=15 Participants
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 3: DS-1040b 60 mg
n=20 Participants
Participants who received an intravenous infusion of 60 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
|---|---|---|---|---|---|---|
|
Mean Percent Change From Baseline in Total Thrombus Volume at 12-72 Hours Post Start of Infusion of DS-1040b Compared to Placebo When Added to Standard of Care Anticoagulation Therapy in Participants With Acute Submassive Pulmonary Embolism
|
-37.36 percent change
Standard Deviation 26.90
|
-32.33 percent change
Standard Deviation 19.03
|
-31.35 percent change
Standard Deviation 17.74
|
-23.78 percent change
Standard Deviation 24.49
|
-38.67 percent change
Standard Deviation 17.34
|
-33.50 percent change
Standard Deviation 17.41
|
SECONDARY outcome
Timeframe: Baseline to 12-72 hours post start of infusion, up to approximately 3 years 2 monthsPopulation: Reductions in total thrombus volume were assessed in the Efficacy Analysis Set.
Change in total pulmonary thrombus burden (total thrombus volume) was assessed by computed tomography pulmonary angiography (CTPA). All CTPA scans were evaluated by a central imaging laboratory in a blinded manner by radiologists.
Outcome measures
| Measure |
Cohort 4: DS-1040b 80 mg
n=22 Participants
Participants who received an intravenous infusion of 80 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 5: DS-1040b 40 mg
n=17 Participants
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Placebo
n=38 Participants
Participants who received an intravenous infusion of placebo in addition to standard of care anticoagulation therapy.
|
Cohort 1: DS-1040b 20 mg
n=12 Participants
Participants who received an intravenous infusion of 20 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 2: DS-1040b 40 mg
n=15 Participants
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 3: DS-1040b 60 mg
n=20 Participants
Participants who received an intravenous infusion of 60 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
|---|---|---|---|---|---|---|
|
Participants Achieving Reductions in Total Thrombus Volume at 12-72 Hours Post Infusion of DS-1040b Compared to Placebo When Added to Standard of Care Anticoagulation Therapy in Participants With Acute Submassive Pulmonary Embolism
≥20% reduction
|
17 Participants
|
12 Participants
|
28 Participants
|
7 Participants
|
12 Participants
|
16 Participants
|
|
Participants Achieving Reductions in Total Thrombus Volume at 12-72 Hours Post Infusion of DS-1040b Compared to Placebo When Added to Standard of Care Anticoagulation Therapy in Participants With Acute Submassive Pulmonary Embolism
Missing data
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Participants Achieving Reductions in Total Thrombus Volume at 12-72 Hours Post Infusion of DS-1040b Compared to Placebo When Added to Standard of Care Anticoagulation Therapy in Participants With Acute Submassive Pulmonary Embolism
No change or increase
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Participants Achieving Reductions in Total Thrombus Volume at 12-72 Hours Post Infusion of DS-1040b Compared to Placebo When Added to Standard of Care Anticoagulation Therapy in Participants With Acute Submassive Pulmonary Embolism
<20% reduction
|
5 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Cohort 1: 0 up to 72 h post infusion; Cohorts 2 and 3: 0 up to 96 h post infusion; Cohort 4 and 5: 0 up to 120 h post infusionPopulation: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Plasma concentrations at each time point and PK parameter Cmax of DS 1040b was calculated using non-compartmental analysis.
Outcome measures
| Measure |
Cohort 4: DS-1040b 80 mg
n=22 Participants
Participants who received an intravenous infusion of 80 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 5: DS-1040b 40 mg
n=17 Participants
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Placebo
Participants who received an intravenous infusion of placebo in addition to standard of care anticoagulation therapy.
|
Cohort 1: DS-1040b 20 mg
n=11 Participants
Participants who received an intravenous infusion of 20 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 2: DS-1040b 40 mg
n=15 Participants
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 3: DS-1040b 60 mg
n=19 Participants
Participants who received an intravenous infusion of 60 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter Maximum Concentration (CMax) Following Intravenous Infusion of DS-1040b in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism
|
1006.41 ng/mL
Standard Deviation 1883.49
|
526.12 ng/mL
Standard Deviation 535.03
|
—
|
970.09 ng/mL
Standard Deviation 1373.43
|
421.73 ng/mL
Standard Deviation 515.57
|
608.84 ng/mL
Standard Deviation 562.94
|
SECONDARY outcome
Timeframe: Cohort 1: 0 up to 72 h post infusion; Cohorts 2 and 3: 0 up to 96 h post infusion; Cohort 4 and 5: 0 up to 120 h post infusionPopulation: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Plasma concentrations at each time point and PK parameter of Area Under the Concentration Versus Time Curve (0 to last) of DS-1040b was calculated using non-compartmental analysis.
Outcome measures
| Measure |
Cohort 4: DS-1040b 80 mg
n=22 Participants
Participants who received an intravenous infusion of 80 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 5: DS-1040b 40 mg
n=17 Participants
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Placebo
Participants who received an intravenous infusion of placebo in addition to standard of care anticoagulation therapy.
|
Cohort 1: DS-1040b 20 mg
n=11 Participants
Participants who received an intravenous infusion of 20 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 2: DS-1040b 40 mg
n=15 Participants
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 3: DS-1040b 60 mg
n=19 Participants
Participants who received an intravenous infusion of 60 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve (0 to Last) Following Intravenous Infusion of DS-1040b In Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism
|
17147.27 ng*h/mL
Standard Deviation 15024.61
|
8014.73 ng*h/mL
Standard Deviation 2870.19
|
—
|
5532.92 ng*h/mL
Standard Deviation 4090.34
|
7819.53 ng*h/mL
Standard Deviation 2870.13
|
13403.15 ng*h/mL
Standard Deviation 8047.13
|
SECONDARY outcome
Timeframe: Cohort 1: 0 up to 72 h post infusion; Cohorts 2 and 3: 0 up to 96 h post infusion; Cohort 4 and 5: 0 up to 120 h post infusionPopulation: Terminal half-life was assessed in patients with available data in the Pharmacokinetic Analysis Set.
Plasma concentrations at each time point and PK parameter Terminal Half-life of DS-1040b was calculated using non-compartmental analysis.
Outcome measures
| Measure |
Cohort 4: DS-1040b 80 mg
n=5 Participants
Participants who received an intravenous infusion of 80 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 5: DS-1040b 40 mg
n=9 Participants
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Placebo
Participants who received an intravenous infusion of placebo in addition to standard of care anticoagulation therapy.
|
Cohort 1: DS-1040b 20 mg
n=9 Participants
Participants who received an intravenous infusion of 20 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 2: DS-1040b 40 mg
n=13 Participants
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 3: DS-1040b 60 mg
n=18 Participants
Participants who received an intravenous infusion of 60 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter Terminal Half-life Following Intravenous Infusion of DS-1040b Combined With Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism
|
36.39 hours
Standard Deviation 2.07
|
30.06 hours
Standard Deviation 3.45
|
—
|
22.81 hours
Standard Deviation 3.13
|
28.44 hours
Standard Deviation 5.75
|
29.06 hours
Standard Deviation 7.60
|
Adverse Events
Cohort 1: DS-1040b 20 mg
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 2: DS-1040b 40 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 3: DS-1040b 60 mg
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 4: DS-1040b 80 mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 5: DS-1040b 40 mg
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: DS-1040b 20 mg
n=12 participants at risk
Participants who received an intravenous infusion of 20 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 2: DS-1040b 40 mg
n=16 participants at risk
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 3: DS-1040b 60 mg
n=20 participants at risk
Participants who received an intravenous infusion of 60 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 4: DS-1040b 80 mg
n=22 participants at risk
Participants who received an intravenous infusion of 80 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 5: DS-1040b 40 mg
n=17 participants at risk
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Placebo
n=38 participants at risk
Participants who received an intravenous infusion of placebo in addition to standard of care anticoagulation therapy.
|
|---|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Infections and infestations
Lung infection
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Psychiatric disorders
Depression
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to nervous system
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular cancer metastatic
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Infections and infestations
Infection
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
Other adverse events
| Measure |
Cohort 1: DS-1040b 20 mg
n=12 participants at risk
Participants who received an intravenous infusion of 20 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 2: DS-1040b 40 mg
n=16 participants at risk
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 3: DS-1040b 60 mg
n=20 participants at risk
Participants who received an intravenous infusion of 60 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 4: DS-1040b 80 mg
n=22 participants at risk
Participants who received an intravenous infusion of 80 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Cohort 5: DS-1040b 40 mg
n=17 participants at risk
Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
|
Placebo
n=38 participants at risk
Participants who received an intravenous infusion of placebo in addition to standard of care anticoagulation therapy.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
12.5%
2/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
10.0%
2/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
7.9%
3/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
15.0%
3/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
9.1%
2/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
7.9%
3/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
10.0%
2/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.3%
2/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Infections and infestations
Lung infection
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
10.0%
2/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.3%
2/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
6.2%
1/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
10.0%
2/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.3%
2/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
6.2%
1/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
10.0%
2/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.3%
2/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.3%
2/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.3%
2/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
11.8%
2/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
10.0%
2/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
6.2%
1/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to nervous system
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular cancer metastatic
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
10.0%
2/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Psychiatric disorders
Depression
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Nervous system disorders
Migraine
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Eye disorders
Vision blurred
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Vascular disorders
Deep vein thrombosis
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Vascular disorders
Hypertension
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Vascular disorders
Hypotension
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
6.2%
1/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
6.2%
1/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
10.0%
2/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
6.2%
1/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
10.0%
2/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
6.2%
1/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
6.2%
1/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
6.2%
1/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
6.2%
1/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
6.2%
1/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
General disorders
Chest pain
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
6.2%
1/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
General disorders
Infusion site phlebitis
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
General disorders
Malaise
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
General disorders
Peripheral swelling
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
6.2%
1/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Investigations
Electrocardiogram QT prolonged
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Investigations
Liver function test increased
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Investigations
Blood pressure increased
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
5.0%
1/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Infections and infestations
Infection
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Nervous system disorders
Tremor
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Renal and urinary disorders
Ketonuria
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
General disorders
Feeling cold
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
General disorders
Feeling hot
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Investigations
Crystal urine present
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Investigations
Electrocardiogram ST segment abnormal
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Investigations
Mean cell volume increased
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Investigations
Occult blood positive
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Investigations
Urobilinogen urine increased
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
4.5%
1/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
|
Surgical and medical procedures
Sinus operation
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/22 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
2.6%
1/38 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to Day 30 post infusion, up to approximately 3 years 2 months.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pre-treatment state.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place