Trial Outcomes & Findings for A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome (NCT NCT05643794)
NCT ID: NCT05643794
Last Updated: 2025-07-01
Results Overview
The BPI-SF was a self-administered questionnaire used to evaluate the severity of a study participant's pain and the impact of this pain on the study participant's daily functioning. The BPI-SF assesses for the location of pain, pain intensity and functional interference from pain. The 7 BPI-SF interference items included: general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. Each item was rated on a 0 (did not interfere) to 10 (completely interfere) scale with a recall period of 24 hours. The BPI-SF interference score ranges 0-70. Higher scores indicated greater interference.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
At 12 weeks of treatment
Results posted on
2025-07-01
Participant Flow
The study started to enroll participants in December 2022 and concluded in July 2024.
The Participant Flow refers to the Randomized Set.
Participant milestones
| Measure |
Sequence 1: RLZ 12w + RLZ 12w
Participants received placebo, subcutaneously (SC), once weekly (QW) for 2 weeks (Run-in Period), then rozanolixizumab (RLZ) 560 milligrams (mg), SC, QW, weekly (w) for 24 weeks (Treatment Period 1 + Treatment Period 2), followed by placebo SC, QW for 2 weeks (Runout Period). The safety follow-up (SFU) included all the participants who received the investigational medicinal product (IMP), regardless of discontinuation.
|
Sequence 2: PBO + RLZ 12w
Participants received placebo SC, QW for 2 weeks (Run-in Period), then placebo SC, QW for 12 weeks (Treatment Period 1), followed by rozanolixizumab 560 mg, SC, QW for 12 weeks (Treatment Period 2), followed by placebo SC, QW for 2 weeks (Runout Period). The SFU included all the participants who received the IMP, regardless of discontinuation.
|
Sequence 3: PBO + PBO
Participants received placebo SC, QW for 2 weeks (Run-in Period), then placebo SC, QW for 24 weeks (Treatment Period 1 + Treatment Period 2), followed by placebo SC, QW for 2 weeks (Run-out Period). The SFU included all the participants who received the IMP, regardless of discontinuation.
|
|---|---|---|---|
|
Run-In (2 Weeks)
STARTED
|
22
|
20
|
21
|
|
Run-In (2 Weeks)
COMPLETED
|
22
|
20
|
21
|
|
Run-In (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
|
Treatment Period 1 (12 Weeks)
STARTED
|
22
|
20
|
21
|
|
Treatment Period 1 (12 Weeks)
COMPLETED
|
19
|
19
|
20
|
|
Treatment Period 1 (12 Weeks)
NOT COMPLETED
|
3
|
1
|
1
|
|
Treatment Period 2 (12 Weeks)
STARTED
|
19
|
19
|
20
|
|
Treatment Period 2 (12 Weeks)
COMPLETED
|
17
|
18
|
20
|
|
Treatment Period 2 (12 Weeks)
NOT COMPLETED
|
2
|
1
|
0
|
|
Run-Out Period (2 Weeks)
STARTED
|
17
|
18
|
20
|
|
Run-Out Period (2 Weeks)
COMPLETED
|
17
|
18
|
20
|
|
Run-Out Period (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
|
Safety Follow-up Period (5 Weeks)
STARTED
|
22
|
20
|
21
|
|
Safety Follow-up Period (5 Weeks)
COMPLETED
|
22
|
20
|
21
|
|
Safety Follow-up Period (5 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1: RLZ 12w + RLZ 12w
Participants received placebo, subcutaneously (SC), once weekly (QW) for 2 weeks (Run-in Period), then rozanolixizumab (RLZ) 560 milligrams (mg), SC, QW, weekly (w) for 24 weeks (Treatment Period 1 + Treatment Period 2), followed by placebo SC, QW for 2 weeks (Runout Period). The safety follow-up (SFU) included all the participants who received the investigational medicinal product (IMP), regardless of discontinuation.
|
Sequence 2: PBO + RLZ 12w
Participants received placebo SC, QW for 2 weeks (Run-in Period), then placebo SC, QW for 12 weeks (Treatment Period 1), followed by rozanolixizumab 560 mg, SC, QW for 12 weeks (Treatment Period 2), followed by placebo SC, QW for 2 weeks (Runout Period). The SFU included all the participants who received the IMP, regardless of discontinuation.
|
Sequence 3: PBO + PBO
Participants received placebo SC, QW for 2 weeks (Run-in Period), then placebo SC, QW for 24 weeks (Treatment Period 1 + Treatment Period 2), followed by placebo SC, QW for 2 weeks (Run-out Period). The SFU included all the participants who received the IMP, regardless of discontinuation.
|
|---|---|---|---|
|
Treatment Period 1 (12 Weeks)
Adverse Event
|
2
|
0
|
1
|
|
Treatment Period 1 (12 Weeks)
Lost to Follow-up
|
1
|
0
|
0
|
|
Treatment Period 1 (12 Weeks)
Consent Withdrawn by Study Participant (Not Due to Adverse Event)
|
0
|
1
|
0
|
|
Treatment Period 2 (12 Weeks)
Lack of Efficacy
|
0
|
1
|
0
|
|
Treatment Period 2 (12 Weeks)
Consent Withdrawn by Study Participant (Not Due to Adverse Event)
|
1
|
0
|
0
|
|
Treatment Period 2 (12 Weeks)
New Work Commitments
|
1
|
0
|
0
|
Baseline Characteristics
A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome
Baseline characteristics by cohort
| Measure |
Sequence 1: RLZ 12w + RLZ 12w
n=22 Participants
Participants received placebo, subcutaneously (SC), once weekly (QW) for 2 weeks (Run-in Period), then rozanolixizumab (RLZ) 560 milligrams (mg), SC, QW, weekly (w) for 24 weeks (Treatment Period 1 + Treatment Period 2), followed by placebo SC, QW for 2 weeks (Runout Period). The safety follow-up (SFU) included all the participants who received the investigational medicinal product (IMP), regardless of discontinuation.
|
Sequence 2: PBO + RLZ 12w
n=20 Participants
Participants received placebo SC, QW for 2 weeks (Run-in Period), then placebo SC, QW for 12 weeks (Treatment Period 1), followed by rozanolixizumab 560 mg, SC, QW for 12 weeks (Treatment Period 2), followed by placebo SC, QW for 2 weeks (Runout Period). The SFU included all the participants who received the IMP, regardless of discontinuation.
|
Sequence 3: PBO + PBO
n=21 Participants
Participants received placebo SC, QW for 2 weeks (Run-in Period), then placebo SC, QW for 24 weeks (Treatment Period 1 + Treatment Period 2), followed by placebo SC, QW for 2 weeks (Run-out Period). The SFU included all the participants who received the IMP, regardless of discontinuation.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
47.8 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
47.3 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At 12 weeks of treatmentPopulation: Full Analysis Set (FAS) included all study participants who received any study treatment, including during the run-in period, had a baseline value and at least one post-baseline efficacy endpoint assessment.
The BPI-SF was a self-administered questionnaire used to evaluate the severity of a study participant's pain and the impact of this pain on the study participant's daily functioning. The BPI-SF assesses for the location of pain, pain intensity and functional interference from pain. The 7 BPI-SF interference items included: general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. Each item was rated on a 0 (did not interfere) to 10 (completely interfere) scale with a recall period of 24 hours. The BPI-SF interference score ranges 0-70. Higher scores indicated greater interference.
Outcome measures
| Measure |
Placebo (PBO)
n=41 Participants
Participants received a PBO SC QW exposure up to 12 weeks and/or extended exposure from 12 to 24 weeks.
|
RLZ 12 Weeks
n=41 Participants
Participants who received 12 weeks of RLZ 560 mg SC treatment during any sequence.
|
TP1-PBO
Participants received a PBO SC QW in TP1 up to Week 12. Pooled data is reported for placebo (Sequence 2 and Sequence 3).
|
TP2-RLZ/RLZ
Participants who received RLZ in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24. One participant of "TP2-RLZ/RLZ" arm started TP2 but discontinued before receiving IMP.
|
TP2-PBO/RLZ
Participants who received PBO in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24.
|
TP2-PBO/PBO
Participants who received PBO in TP1 continued PBO SC in Treatment Period 2 (TP2) up to Week 24.
|
Run-Out and SFU-RLZ/RLZ
Participants who received RLZ in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had safety-follow-up (SFU), up to 5 weeks.
|
Run-Out and SFU-PBO/RLZ
Participants who received PBO in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
|
Run-Out and SFU-PBO/PBO
Participants who received PBO in TP1 and continued PBO SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Brief Pain Inventory Short Form (BPI-SF) Average Interference Score at 12 Weeks of Treatment
|
6.30 score on a scale
Interval 5.59 to 7.01
|
5.76 score on a scale
Interval 5.11 to 6.41
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline till end of Safety Follow-up (up to Week 33)Population: The Safety Set as treated (SS-t) included all study participants who received any study treatment, including during Run-In period.
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE was defined as any AE with an onset date on or after the first dose of investigational medicinal product (IMP) in Run-In and on or before the earliest of the following: the last date of infusion (including Run-Out) +56 days, final contact date, or death. A TEAE is also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
Outcome measures
| Measure |
Placebo (PBO)
n=63 Participants
Participants received a PBO SC QW exposure up to 12 weeks and/or extended exposure from 12 to 24 weeks.
|
RLZ 12 Weeks
n=22 Participants
Participants who received 12 weeks of RLZ 560 mg SC treatment during any sequence.
|
TP1-PBO
n=41 Participants
Participants received a PBO SC QW in TP1 up to Week 12. Pooled data is reported for placebo (Sequence 2 and Sequence 3).
|
TP2-RLZ/RLZ
n=18 Participants
Participants who received RLZ in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24. One participant of "TP2-RLZ/RLZ" arm started TP2 but discontinued before receiving IMP.
|
TP2-PBO/RLZ
n=19 Participants
Participants who received PBO in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24.
|
TP2-PBO/PBO
n=20 Participants
Participants who received PBO in TP1 continued PBO SC in Treatment Period 2 (TP2) up to Week 24.
|
Run-Out and SFU-RLZ/RLZ
n=22 Participants
Participants who received RLZ in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had safety-follow-up (SFU), up to 5 weeks.
|
Run-Out and SFU-PBO/RLZ
n=20 Participants
Participants who received PBO in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
|
Run-Out and SFU-PBO/PBO
n=21 Participants
Participants who received PBO in TP1 and continued PBO SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
|
44 Participants
|
22 Participants
|
41 Participants
|
18 Participants
|
19 Participants
|
19 Participants
|
10 Participants
|
12 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: From Baseline till end of Safety Follow-up (up to Week 33)Population: The SS-t included all study participants who received any study treatment, including during Run-In period.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE was defined as any AE with an onset date on or after the first dose of IMP in Run-In and on or before the earliest of the following: the last date of infusion (including Run-Out) +56 days, final contact date, or death.
Outcome measures
| Measure |
Placebo (PBO)
n=63 Participants
Participants received a PBO SC QW exposure up to 12 weeks and/or extended exposure from 12 to 24 weeks.
|
RLZ 12 Weeks
n=22 Participants
Participants who received 12 weeks of RLZ 560 mg SC treatment during any sequence.
|
TP1-PBO
n=41 Participants
Participants received a PBO SC QW in TP1 up to Week 12. Pooled data is reported for placebo (Sequence 2 and Sequence 3).
|
TP2-RLZ/RLZ
n=18 Participants
Participants who received RLZ in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24. One participant of "TP2-RLZ/RLZ" arm started TP2 but discontinued before receiving IMP.
|
TP2-PBO/RLZ
n=19 Participants
Participants who received PBO in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24.
|
TP2-PBO/PBO
n=20 Participants
Participants who received PBO in TP1 continued PBO SC in Treatment Period 2 (TP2) up to Week 24.
|
Run-Out and SFU-RLZ/RLZ
n=22 Participants
Participants who received RLZ in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had safety-follow-up (SFU), up to 5 weeks.
|
Run-Out and SFU-PBO/RLZ
n=20 Participants
Participants who received PBO in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
|
Run-Out and SFU-PBO/PBO
n=21 Participants
Participants who received PBO in TP1 and continued PBO SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs Leading to Withdrawal of IMP
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At 24 weeks of treatmentPopulation: FAS included all study participants who received any study treatment, including during the run-in period, had a baseline value and at least one post-baseline efficacy endpoint assessment. Here 'overall number of participants analyzed' signifies participants evaluable for this Outcome measure.
The BPI-SF was a self-administered questionnaire used to evaluate the severity of a study participant's pain and the impact of this pain on the study participant's daily functioning. The BPI-SF assesses for the location of pain, pain intensity and functional interference from pain. The 7 BPI-SF interference items included: general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. Each item was rated on a 0 (did not interfere) to 10 (completely interfere) scale with a recall period of 24 hours. The BPI-SF interference score ranges 0-70. Higher scores indicated greater interference.
Outcome measures
| Measure |
Placebo (PBO)
n=41 Participants
Participants received a PBO SC QW exposure up to 12 weeks and/or extended exposure from 12 to 24 weeks.
|
RLZ 12 Weeks
n=18 Participants
Participants who received 12 weeks of RLZ 560 mg SC treatment during any sequence.
|
TP1-PBO
Participants received a PBO SC QW in TP1 up to Week 12. Pooled data is reported for placebo (Sequence 2 and Sequence 3).
|
TP2-RLZ/RLZ
Participants who received RLZ in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24. One participant of "TP2-RLZ/RLZ" arm started TP2 but discontinued before receiving IMP.
|
TP2-PBO/RLZ
Participants who received PBO in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24.
|
TP2-PBO/PBO
Participants who received PBO in TP1 continued PBO SC in Treatment Period 2 (TP2) up to Week 24.
|
Run-Out and SFU-RLZ/RLZ
Participants who received RLZ in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had safety-follow-up (SFU), up to 5 weeks.
|
Run-Out and SFU-PBO/RLZ
Participants who received PBO in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
|
Run-Out and SFU-PBO/PBO
Participants who received PBO in TP1 and continued PBO SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Brief Pain Inventory Short Form (BPI-SF) Average Interference Score at 24 Weeks of Treatment
|
6.30 score on a scale
Interval 5.59 to 7.01
|
5.79 score on a scale
Interval 4.97 to 6.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 12 weeks of treatmentPopulation: FAS included all study participants who received any study treatment, including during the run-in period, had a baseline value and at least one post-baseline efficacy endpoint assessment.
The Revised Fibromyalgia Impact Questionnaire (FIQR) was a 21-item questionnaire with a recall period of 7 days. The FIQR included 3 domains: activities, overall impact, and symptoms. Each item was based on an 11-point numeric rating scale. The FIQR total score was calculated by taking the sum of the following: Activities domain subtotal divided by 3, overall impact" domain subtotal and symptoms domain subtotal divided by 2. The total score ranged from 0 to 100, with 0 denoting the best possible condition and 100 denoting the worst possible condition. Higher scores indicated more severe impact.
Outcome measures
| Measure |
Placebo (PBO)
n=41 Participants
Participants received a PBO SC QW exposure up to 12 weeks and/or extended exposure from 12 to 24 weeks.
|
RLZ 12 Weeks
n=41 Participants
Participants who received 12 weeks of RLZ 560 mg SC treatment during any sequence.
|
TP1-PBO
Participants received a PBO SC QW in TP1 up to Week 12. Pooled data is reported for placebo (Sequence 2 and Sequence 3).
|
TP2-RLZ/RLZ
Participants who received RLZ in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24. One participant of "TP2-RLZ/RLZ" arm started TP2 but discontinued before receiving IMP.
|
TP2-PBO/RLZ
Participants who received PBO in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24.
|
TP2-PBO/PBO
Participants who received PBO in TP1 continued PBO SC in Treatment Period 2 (TP2) up to Week 24.
|
Run-Out and SFU-RLZ/RLZ
Participants who received RLZ in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had safety-follow-up (SFU), up to 5 weeks.
|
Run-Out and SFU-PBO/RLZ
Participants who received PBO in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
|
Run-Out and SFU-PBO/PBO
Participants who received PBO in TP1 and continued PBO SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Revised Fibromyalgia Impact Questionnaire (FIQR) Score at 12 Weeks of Treatment
|
70.70 score on a scale
Interval 64.9 to 76.5
|
62.30 score on a scale
Interval 57.32 to 67.28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 12 Weeks of treatmentPopulation: FAS included all study participants who received any study treatment, including during the run-in period, had a baseline value and at least one post-baseline efficacy endpoint assessment.
The Pain Numeric Rating Scale (NRS) was a scale in which a respondent selected a whole number that best described "How much pain have you experienced on average over the past 24 hours?" The 11-point Pain NRS ranged 0 (no pain) to 10 (pain as bad as you can imagine). Mean pain scores were derived the average of the daily assessment over the past 7 days. The higher score represented worst possible pain.
Outcome measures
| Measure |
Placebo (PBO)
n=41 Participants
Participants received a PBO SC QW exposure up to 12 weeks and/or extended exposure from 12 to 24 weeks.
|
RLZ 12 Weeks
n=41 Participants
Participants who received 12 weeks of RLZ 560 mg SC treatment during any sequence.
|
TP1-PBO
Participants received a PBO SC QW in TP1 up to Week 12. Pooled data is reported for placebo (Sequence 2 and Sequence 3).
|
TP2-RLZ/RLZ
Participants who received RLZ in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24. One participant of "TP2-RLZ/RLZ" arm started TP2 but discontinued before receiving IMP.
|
TP2-PBO/RLZ
Participants who received PBO in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24.
|
TP2-PBO/PBO
Participants who received PBO in TP1 continued PBO SC in Treatment Period 2 (TP2) up to Week 24.
|
Run-Out and SFU-RLZ/RLZ
Participants who received RLZ in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had safety-follow-up (SFU), up to 5 weeks.
|
Run-Out and SFU-PBO/RLZ
Participants who received PBO in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
|
Run-Out and SFU-PBO/PBO
Participants who received PBO in TP1 and continued PBO SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean 7-day Average Daily Pain Score Assessed With Pain Numeric Rating Scale (NRS) at 12 Weeks of Treatment
|
6.59 score on a scale
Interval 5.96 to 7.21
|
6.63 score on a scale
Interval 6.09 to 7.18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 12 weeks of treatmentPopulation: FAS included all study participants who received any study treatment, including during the run-in period, had a baseline value and at least one post-baseline efficacy endpoint assessment.
The Fatigue Numeric Rating Scale (NRS) was a scale in which a respondent selected a whole number that best described "How much fatigue have you experienced on average over the past 24 hours?" The 11-point Fatigue NRS ranged 0 (no fatigue) to 10 (fatigue as bad as you can imagine). Mean fatigue scores were derived the average of the daily assessment over the past 7 days. Higher score represented worst possible fatigue.
Outcome measures
| Measure |
Placebo (PBO)
n=41 Participants
Participants received a PBO SC QW exposure up to 12 weeks and/or extended exposure from 12 to 24 weeks.
|
RLZ 12 Weeks
n=41 Participants
Participants who received 12 weeks of RLZ 560 mg SC treatment during any sequence.
|
TP1-PBO
Participants received a PBO SC QW in TP1 up to Week 12. Pooled data is reported for placebo (Sequence 2 and Sequence 3).
|
TP2-RLZ/RLZ
Participants who received RLZ in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24. One participant of "TP2-RLZ/RLZ" arm started TP2 but discontinued before receiving IMP.
|
TP2-PBO/RLZ
Participants who received PBO in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24.
|
TP2-PBO/PBO
Participants who received PBO in TP1 continued PBO SC in Treatment Period 2 (TP2) up to Week 24.
|
Run-Out and SFU-RLZ/RLZ
Participants who received RLZ in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had safety-follow-up (SFU), up to 5 weeks.
|
Run-Out and SFU-PBO/RLZ
Participants who received PBO in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
|
Run-Out and SFU-PBO/PBO
Participants who received PBO in TP1 and continued PBO SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean 7-day Fatigue Score Assessed With Fatigue Numeric Rating Scale at 12 Weeks of Treatment
|
7.26 score on a scale
Interval 6.66 to 7.86
|
6.98 score on a scale
Interval 6.45 to 7.51
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Run-In-PBO
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
TP1-RLZ
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
TP1-PBO
Serious events: 3 serious events
Other events: 37 other events
Deaths: 0 deaths
TP2-RLZ/RLZ
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
TP2-PBO/RLZ
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
TP2-PBO/PBO
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Run-Out and SFU-RLZ/RLZ
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Run-Out and SFU-PBO/RLZ
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Run-Out and SFU-PBO/PBO
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Run-In-PBO
n=63 participants at risk
Participants received a PBO SC QW for 2 weeks in Run-In period. All study participants received placebo during the Run-in Period.
|
TP1-RLZ
n=22 participants at risk
Participants received RLZ 560 mg SC in TP1 up to Week 12.
|
TP1-PBO
n=41 participants at risk
Participants received PBO SC QW in TP1 up to Week 12. Pooled data is reported for placebo (Sequence 2 and Sequence 3).
|
TP2-RLZ/RLZ
n=18 participants at risk
Participants who received RLZ in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24. One participant of "TP2-RLZ/RLZ" arm started TP2 but discontinued before receiving IMP.
|
TP2-PBO/RLZ
n=19 participants at risk
Participants who received PBO in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24.
|
TP2-PBO/PBO
n=20 participants at risk
Participants who received PBO in TP1 continued PBO SC in Treatment Period 2 (TP2) up to Week 24.
|
Run-Out and SFU-RLZ/RLZ
n=22 participants at risk
Participants who received RLZ in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had safety-follow-up (SFU), up to 5 weeks.
|
Run-Out and SFU-PBO/RLZ
n=20 participants at risk
Participants who received PBO in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
|
Run-Out and SFU-PBO/PBO
n=21 participants at risk
Participants who received PBO in TP1 and continued PBO SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
2.4%
1/41 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
2.4%
1/41 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
2.4%
1/41 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Nervous system disorders
Headache
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.8%
1/21 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.0%
1/20 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.8%
1/21 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
Other adverse events
| Measure |
Run-In-PBO
n=63 participants at risk
Participants received a PBO SC QW for 2 weeks in Run-In period. All study participants received placebo during the Run-in Period.
|
TP1-RLZ
n=22 participants at risk
Participants received RLZ 560 mg SC in TP1 up to Week 12.
|
TP1-PBO
n=41 participants at risk
Participants received PBO SC QW in TP1 up to Week 12. Pooled data is reported for placebo (Sequence 2 and Sequence 3).
|
TP2-RLZ/RLZ
n=18 participants at risk
Participants who received RLZ in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24. One participant of "TP2-RLZ/RLZ" arm started TP2 but discontinued before receiving IMP.
|
TP2-PBO/RLZ
n=19 participants at risk
Participants who received PBO in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24.
|
TP2-PBO/PBO
n=20 participants at risk
Participants who received PBO in TP1 continued PBO SC in Treatment Period 2 (TP2) up to Week 24.
|
Run-Out and SFU-RLZ/RLZ
n=22 participants at risk
Participants who received RLZ in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had safety-follow-up (SFU), up to 5 weeks.
|
Run-Out and SFU-PBO/RLZ
n=20 participants at risk
Participants who received PBO in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
|
Run-Out and SFU-PBO/PBO
n=21 participants at risk
Participants who received PBO in TP1 and continued PBO SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Pain
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
9.1%
2/22 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
2.4%
1/41 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
10.5%
2/19 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
18.2%
4/22 • Number of events 7 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 4 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Immune system disorders
Type IV hypersensitivity reaction
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.5%
1/22 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 6 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.3%
4/63 • Number of events 4 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
13.6%
3/22 • Number of events 7 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
7.3%
3/41 • Number of events 4 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
36.8%
7/19 • Number of events 7 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.0%
1/20 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Nervous system disorders
Headache
|
17.5%
11/63 • Number of events 13 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
40.9%
9/22 • Number of events 14 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
41.5%
17/41 • Number of events 22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
22.2%
4/18 • Number of events 5 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
36.8%
7/19 • Number of events 7 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
15.0%
3/20 • Number of events 4 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
20.0%
4/20 • Number of events 5 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
9.1%
2/22 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
2.4%
1/41 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.9%
2/41 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.9%
2/41 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.0%
1/20 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.5%
1/22 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.9%
2/41 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.0%
1/20 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.9%
2/41 • Number of events 3 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.0%
1/20 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Gastrointestinal disorders
Nausea
|
17.5%
11/63 • Number of events 13 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
18.2%
4/22 • Number of events 9 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
9.8%
4/41 • Number of events 5 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
16.7%
3/18 • Number of events 5 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
21.1%
4/19 • Number of events 4 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
15.0%
3/20 • Number of events 3 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
9.1%
2/22 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
7.3%
3/41 • Number of events 4 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
10.5%
2/19 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.5%
1/22 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
2.4%
1/41 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
General disorders
Fatigue
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
13.6%
3/22 • Number of events 3 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
14.6%
6/41 • Number of events 6 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.0%
1/20 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
General disorders
Pyrexia
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
9.1%
2/22 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.0%
1/20 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
General disorders
Influenza like illness
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
9.1%
2/22 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
General disorders
Catheter site urticaria
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.5%
1/22 • Number of events 12 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 14 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
General disorders
Infusion site bruising
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
2.4%
1/41 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
General disorders
Infusion site erythema
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
15.8%
3/19 • Number of events 4 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
General disorders
Infusion site hypersensitivity
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
10.5%
2/19 • Number of events 4 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
General disorders
Infusion site pain
|
6.3%
4/63 • Number of events 4 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
12.2%
5/41 • Number of events 13 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
10.5%
2/19 • Number of events 6 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
20.0%
4/20 • Number of events 8 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
General disorders
Infusion site reaction
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
9.1%
2/22 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 7 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
General disorders
Injection site bruising
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
2.4%
1/41 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
General disorders
Injection site erythema
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.5%
1/22 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
10.0%
2/20 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
General disorders
Injection site pruritus
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
General disorders
Injection site reaction
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
9.1%
2/22 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
General disorders
Oedema peripheral
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
9.1%
2/22 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
2.4%
1/41 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.0%
1/20 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Infections and infestations
COVID-19
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
9.1%
2/22 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.9%
2/41 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
2.4%
1/41 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.0%
1/20 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
9.1%
2/22 • Number of events 3 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
9.8%
4/41 • Number of events 4 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Infections and infestations
Infected bite
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.5%
1/22 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.9%
2/41 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.0%
1/20 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.5%
1/22 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
10.0%
2/20 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
22.7%
5/22 • Number of events 5 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
14.6%
6/41 • Number of events 8 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
22.2%
4/18 • Number of events 4 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
10.5%
2/19 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
10.0%
2/20 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
14.6%
6/41 • Number of events 6 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
20.0%
4/20 • Number of events 4 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
9.1%
2/22 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
9.5%
2/21 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
9.8%
4/41 • Number of events 4 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.0%
1/20 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
9.1%
2/22 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.9%
2/41 • Number of events 3 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
30.0%
6/20 • Number of events 8 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
10.0%
2/20 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.5%
1/22 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.5%
1/22 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
7.3%
3/41 • Number of events 3 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
2.4%
1/41 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Nervous system disorders
Syncope
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
2.4%
1/41 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.5%
1/22 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
11.1%
2/18 • Number of events 3 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
10.5%
2/19 • Number of events 3 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.0%
1/20 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
2.4%
1/41 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Investigations
Blood folate decreased
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.5%
1/22 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.9%
2/41 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
15.8%
3/19 • Number of events 3 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
10.0%
2/20 • Number of events 3 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.5%
1/22 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
7.3%
3/41 • Number of events 4 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
10.5%
2/19 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
10.0%
2/20 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
10.0%
2/20 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.8%
1/21 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
7.3%
3/41 • Number of events 3 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
2.4%
1/41 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.0%
1/20 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.5%
1/22 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.0%
1/20 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.8%
1/21 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
2.4%
1/41 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Nervous system disorders
Migraine
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
13.6%
3/22 • Number of events 4 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.9%
2/41 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.0%
1/20 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
9.1%
2/22 • Number of events 3 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
2.4%
1/41 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
2.4%
1/41 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
2.4%
1/41 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Nervous system disorders
Tremor
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
2.4%
1/41 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.5%
1/22 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
9.8%
4/41 • Number of events 4 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.5%
1/22 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
2.4%
1/41 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.5%
1/22 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Reproductive system and breast disorders
Mammary duct ectasia
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
7.3%
3/41 • Number of events 5 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.0%
1/20 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.5%
1/22 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
9.8%
4/41 • Number of events 4 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.0%
1/20 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.3%
1/19 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.5%
1/22 • Number of events 3 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/18 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
15.8%
3/19 • Number of events 4 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/63 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
4.5%
1/22 • Number of events 2 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/41 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
5.6%
1/18 • Number of events 1 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/19 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/22 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/20 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
0.00%
0/21 • From Baseline till end of Safety Follow-up (up to Week 33)
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60