Trial Outcomes & Findings for Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children (NCT NCT02106351)
NCT ID: NCT02106351
Last Updated: 2022-09-28
Results Overview
The MAS was used to assess muscle tone in the upper limb PTMG and consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM) when the affected part is moved in flexion or extension, 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension). The original score '+1' was given a derived numeric score of '2' and the higher numeric scores were incremented by 1 so that the MAS score range was from 0 to 5 with higher scores indicating greater muscle tone. A negative change from baseline indicates a decrease in muscle tone.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
212 participants
Primary outcome timeframe
Baseline (TC 1, Day 1) and TC 1, Week 6.
Results posted on
2022-09-28
Participant Flow
Male and female subjects aged between 2 and 17 years with upper limb spasticity due to cerebral palsy (CP) were recruited from April 2014 and the study completed in September 2018. Subjects could receive a maximum of 4 treatment cycles (TC) over a minimum of 1 year and maximum of 1 year and 9 months, with at least 16 weeks between each TC.
Subjects had a body weight ≥10 kilograms (kg), increased muscle tone/spasticity in at least 1 upper limb, a modified Ashworth scale (MAS) score ≥2 in the upper limb primary targeted muscle group (PTMG) of the study limb at baseline. Subjects were stratified according to age (2-9 and 10-17 years) and Botulinum Toxin (BTX) naïve or non-naïve status.
Participant milestones
| Measure |
Dysport 2 U/kg
Subjects were randomised to receive Dysport 2 Units per kg (U/kg) by intramuscular (IM) injection into the study upper limb in TC 1 and Dysport 8 U/kg or 16 U/kg in subsequent TCs (2, 3 and 4). Retreatment was based on clinical need with a minimum retreatment interval of 16 weeks. In all TCs the dose was divided between the PTMG (elbow or wrist flexors) and a number of other upper limb muscles based on clinical presentation. From TC 2 onwards dose adaptation was permitted as well as treatment of the non-study upper limb and lower limbs.
|
Dysport 8 U/kg
Subjects were randomised to receive Dysport 8 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 320 U. Retreatment was based on clinical need with a minimum retreatment interval of 16 weeks. In all TCs the dose was divided between the PTMG (elbow or wrist flexors) and a number of other upper limb muscles based on clinical presentation. From TC 2 onwards dose adaptation was permitted as well as treatment of the non-study upper limb and lower limbs.
|
Dysport 16 U/kg
Subjects were randomised to receive Dysport 16 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 640 U. Retreatment was based on clinical need with a minimum retreatment interval of 16 weeks. In all TCs the dose was divided between the PTMG (elbow or wrist flexors) and a number of other upper limb muscles based on clinical presentation. From TC 2 onwards dose adaptation was permitted as well as treatment of the non-study upper limb and lower limbs.
|
|---|---|---|---|
|
Treatment Cycle 1
STARTED
|
71
|
70
|
71
|
|
Treatment Cycle 1
Received Treatment in TC 1
|
70
|
70
|
70
|
|
Treatment Cycle 1
COMPLETED
|
66
|
67
|
67
|
|
Treatment Cycle 1
NOT COMPLETED
|
5
|
3
|
4
|
|
Treatment Cycle 2
STARTED
|
0
|
88
|
90
|
|
Treatment Cycle 2
COMPLETED
|
0
|
83
|
87
|
|
Treatment Cycle 2
NOT COMPLETED
|
0
|
5
|
3
|
|
Treatment Cycle 3
STARTED
|
0
|
49
|
58
|
|
Treatment Cycle 3
COMPLETED
|
0
|
45
|
53
|
|
Treatment Cycle 3
NOT COMPLETED
|
0
|
4
|
5
|
|
Treatment Cycle 4
STARTED
|
0
|
22
|
33
|
|
Treatment Cycle 4
COMPLETED
|
0
|
21
|
31
|
|
Treatment Cycle 4
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Dysport 2 U/kg
Subjects were randomised to receive Dysport 2 Units per kg (U/kg) by intramuscular (IM) injection into the study upper limb in TC 1 and Dysport 8 U/kg or 16 U/kg in subsequent TCs (2, 3 and 4). Retreatment was based on clinical need with a minimum retreatment interval of 16 weeks. In all TCs the dose was divided between the PTMG (elbow or wrist flexors) and a number of other upper limb muscles based on clinical presentation. From TC 2 onwards dose adaptation was permitted as well as treatment of the non-study upper limb and lower limbs.
|
Dysport 8 U/kg
Subjects were randomised to receive Dysport 8 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 320 U. Retreatment was based on clinical need with a minimum retreatment interval of 16 weeks. In all TCs the dose was divided between the PTMG (elbow or wrist flexors) and a number of other upper limb muscles based on clinical presentation. From TC 2 onwards dose adaptation was permitted as well as treatment of the non-study upper limb and lower limbs.
|
Dysport 16 U/kg
Subjects were randomised to receive Dysport 16 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 640 U. Retreatment was based on clinical need with a minimum retreatment interval of 16 weeks. In all TCs the dose was divided between the PTMG (elbow or wrist flexors) and a number of other upper limb muscles based on clinical presentation. From TC 2 onwards dose adaptation was permitted as well as treatment of the non-study upper limb and lower limbs.
|
|---|---|---|---|
|
Treatment Cycle 1
Adverse Event
|
2
|
0
|
0
|
|
Treatment Cycle 1
Consent withdrawn
|
1
|
0
|
2
|
|
Treatment Cycle 1
Lost to Follow-up
|
1
|
0
|
0
|
|
Treatment Cycle 1
Other
|
0
|
3
|
1
|
|
Treatment Cycle 1
Randomised but not treated
|
1
|
0
|
1
|
|
Treatment Cycle 2
Adverse Event
|
0
|
2
|
0
|
|
Treatment Cycle 2
Consent withdrawn
|
0
|
1
|
1
|
|
Treatment Cycle 2
Other
|
0
|
2
|
2
|
|
Treatment Cycle 3
Adverse Event
|
0
|
1
|
0
|
|
Treatment Cycle 3
Consent withdrawn
|
0
|
0
|
2
|
|
Treatment Cycle 3
Lost to Follow-up
|
0
|
1
|
0
|
|
Treatment Cycle 3
Other
|
0
|
2
|
3
|
|
Treatment Cycle 4
Consent withdrawn
|
0
|
0
|
2
|
|
Treatment Cycle 4
Other
|
0
|
1
|
0
|
Baseline Characteristics
Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children
Baseline characteristics by cohort
| Measure |
Dysport 2 U/kg
n=70 Participants
Subjects were randomised to receive Dysport 2 U/kg by IM injection into the study upper limb in TC 1 and Dysport 8 U/kg or 16 U/kg in subsequent TCs (2, 3 and 4).
|
Dysport 8 U/kg
n=70 Participants
Subjects were randomised to receive Dysport 8 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 320 U.
|
Dysport 16 U/kg
n=70 Participants
Subjects were randomised to receive Dysport 16 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 640 U.
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
8.91 Years
STANDARD_DEVIATION 4.55 • n=5 Participants
|
8.97 Years
STANDARD_DEVIATION 4.27 • n=7 Participants
|
9.17 Years
STANDARD_DEVIATION 4.30 • n=5 Participants
|
9.02 Years
STANDARD_DEVIATION 4.36 • n=4 Participants
|
|
Age, Customized
2 - 9 Years
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Age, Customized
10 - 17 Years
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
49 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
157 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
166 Participants
n=4 Participants
|
|
BTX Status
BTX naïve
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
BTX Status
BTX non-naïve
|
45 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
|
Baseline MAS Score in the PTMG
|
3.1 score on a scale
STANDARD_DEVIATION 0.3 • n=5 Participants
|
3.1 score on a scale
STANDARD_DEVIATION 0.3 • n=7 Participants
|
3.1 score on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
3.1 score on a scale
STANDARD_DEVIATION 0.4 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (TC 1, Day 1) and TC 1, Week 6.Population: The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6.
The MAS was used to assess muscle tone in the upper limb PTMG and consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM) when the affected part is moved in flexion or extension, 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension). The original score '+1' was given a derived numeric score of '2' and the higher numeric scores were incremented by 1 so that the MAS score range was from 0 to 5 with higher scores indicating greater muscle tone. A negative change from baseline indicates a decrease in muscle tone.
Outcome measures
| Measure |
Dysport 2 U/kg
n=69 Participants
Subjects were randomised to receive Dysport 2 U/kg by IM injection into the study upper limb in TC 1 and Dysport 8 U/kg or 16 U/kg in subsequent TCs (2, 3 and 4).
|
Dysport 8 U/kg
n=69 Participants
Subjects were randomised to receive Dysport 8 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 320 U.
|
Dysport 16 U/kg
n=70 Participants
Subjects were randomised to receive Dysport 16 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 640 U.
|
|---|---|---|---|
|
Mean Change From Baseline to TC 1, Week 6 in MAS Score in the TC 1 PTMG
|
-1.5 score on a scale
Standard Deviation 1.1
|
-1.9 score on a scale
Standard Deviation 1.0
|
-2.2 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: TC 1, Week 6.Population: The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with data available are presented.
The PGA of treatment response was assessed by asking the investigator the following question: 'How would you rate the response to treatment in the subject's upper limb since the start of the study?'. Answers were on a 9-point rating scale (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved and +4: markedly improved). The mean scores for each treatment group at TC 1, Week 6 are presented.
Outcome measures
| Measure |
Dysport 2 U/kg
n=68 Participants
Subjects were randomised to receive Dysport 2 U/kg by IM injection into the study upper limb in TC 1 and Dysport 8 U/kg or 16 U/kg in subsequent TCs (2, 3 and 4).
|
Dysport 8 U/kg
n=69 Participants
Subjects were randomised to receive Dysport 8 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 320 U.
|
Dysport 16 U/kg
n=70 Participants
Subjects were randomised to receive Dysport 16 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 640 U.
|
|---|---|---|---|
|
Mean Physician's Global Assessment (PGA) Score at TC 1, Week 6
|
1.7 score on a scale
Standard Deviation 0.9
|
2.0 score on a scale
Standard Deviation 0.9
|
2.0 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: TC 1, Week 6.Population: The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with data available are presented.
The GAS is a functional 5-point scale used to measure progress towards individual therapy goals. At start of each TC, 1 to 3 individual goals were defined for each subject by investigator and child's parents/guardians/caregivers prior to treatment. Outcome to reach each goal was rated on a 5-point scale ranging from -2 to +2 (-2: much less than expected outcome, -1: somewhat less than expected outcome, 0: expected outcome, +1: somewhat more than expected outcome, +2: much more than expected outcome). Higher score indicates a better outcome. A GAS T-score was calculated as: 50+(10∑\_(i=1)\^n wi xi)/√(0.7∑\_(i=1)\^n wi\^2 +0.3(∑\_(i=1)\^n wi)\^2) where, xi = rating of ith goal post-baseline; wi = weight of ith goal, calculated as importance \* difficulty as defined at baseline; n = number of goals assessed at baseline and post-baseline. A GAS T-score of 50 indicates goals achieved as expected. Scores below 50 reflect under attainment of goals and scores above 50 reflect over attainment of goals.
Outcome measures
| Measure |
Dysport 2 U/kg
n=68 Participants
Subjects were randomised to receive Dysport 2 U/kg by IM injection into the study upper limb in TC 1 and Dysport 8 U/kg or 16 U/kg in subsequent TCs (2, 3 and 4).
|
Dysport 8 U/kg
n=66 Participants
Subjects were randomised to receive Dysport 8 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 320 U.
|
Dysport 16 U/kg
n=70 Participants
Subjects were randomised to receive Dysport 16 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 640 U.
|
|---|---|---|---|
|
Mean Goal Attainment Scale (GAS) Total Score at TC 1, Week 6
|
51.3 T-score
Standard Deviation 9.9
|
52.6 T-score
Standard Deviation 10.1
|
52.0 T-score
Standard Deviation 9.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (TC 1, Day 1) and TC 1, Week 16.Population: The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with data available at the timepoint analysed are presented.
The MAS was used to assess muscle tone in the upper limb PTMG and consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM) when the affected part is moved in flexion or extension, 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension). The original score '+1' was given a derived numeric score of '2' and the higher numeric scores were incremented by 1 so that the MAS score range was from 0 to 5 with higher scores indicating greater muscle tone. A negative change from baseline indicates a decrease in muscle tone.
Outcome measures
| Measure |
Dysport 2 U/kg
n=68 Participants
Subjects were randomised to receive Dysport 2 U/kg by IM injection into the study upper limb in TC 1 and Dysport 8 U/kg or 16 U/kg in subsequent TCs (2, 3 and 4).
|
Dysport 8 U/kg
n=68 Participants
Subjects were randomised to receive Dysport 8 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 320 U.
|
Dysport 16 U/kg
n=68 Participants
Subjects were randomised to receive Dysport 16 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 640 U.
|
|---|---|---|---|
|
Mean Change From Baseline to TC 1 Week 16 in MAS Score in the TC 1 PTMG
|
-1.0 score on a scale
Standard Deviation 1.0
|
-1.4 score on a scale
Standard Deviation 1.1
|
-1.6 score on a scale
Standard Deviation 1.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (TC 1, Day 1) and TC 1, Weeks 6 and 16.Population: The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with data available at each timepoint and who were injected in the elbow flexors are presented.
The MAS was used to assess muscle tone in the upper limb PTMG and consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM) when the affected part is moved in flexion or extension, 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension). The original score '+1' was given a derived numeric score of '2' and the higher numeric scores were incremented by 1 so that the MAS score range was from 0 to 5 with higher scores indicating greater muscle tone. A negative change from baseline indicates a decrease in muscle tone. Data is presented for subjects injected in the elbow flexors.
Outcome measures
| Measure |
Dysport 2 U/kg
n=69 Participants
Subjects were randomised to receive Dysport 2 U/kg by IM injection into the study upper limb in TC 1 and Dysport 8 U/kg or 16 U/kg in subsequent TCs (2, 3 and 4).
|
Dysport 8 U/kg
n=69 Participants
Subjects were randomised to receive Dysport 8 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 320 U.
|
Dysport 16 U/kg
n=70 Participants
Subjects were randomised to receive Dysport 16 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 640 U.
|
|---|---|---|---|
|
Mean Change From Baseline to TC 1 Weeks 6 and 16 in MAS Score in the Elbow Flexors of the Study Limb
Week 6
|
-1.0 score on a scale
Standard Deviation 1.1
|
-1.7 score on a scale
Standard Deviation 1.1
|
-1.9 score on a scale
Standard Deviation 1.2
|
|
Mean Change From Baseline to TC 1 Weeks 6 and 16 in MAS Score in the Elbow Flexors of the Study Limb
Week 16
|
-0.6 score on a scale
Standard Deviation 1.0
|
-1.2 score on a scale
Standard Deviation 1.2
|
-1.3 score on a scale
Standard Deviation 1.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (TC 1, Day 1) and TC 1, Weeks 6 and 16.Population: The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with data available at each timepoint and who were injected in the wrist flexors are presented.
The MAS was used to assess muscle tone in the upper limb PTMG and consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM) when the affected part is moved in flexion or extension, 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension). The original score '+1' was given a derived numeric score of '2' and the higher numeric scores were incremented by 1 so that the MAS score range was from 0 to 5 with higher scores indicating greater muscle tone. A negative change from baseline indicates a decrease in muscle tone. Data is presented for subjects injected in the wrist flexors.
Outcome measures
| Measure |
Dysport 2 U/kg
n=69 Participants
Subjects were randomised to receive Dysport 2 U/kg by IM injection into the study upper limb in TC 1 and Dysport 8 U/kg or 16 U/kg in subsequent TCs (2, 3 and 4).
|
Dysport 8 U/kg
n=69 Participants
Subjects were randomised to receive Dysport 8 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 320 U.
|
Dysport 16 U/kg
n=70 Participants
Subjects were randomised to receive Dysport 16 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 640 U.
|
|---|---|---|---|
|
Mean Change From Baseline to TC 1 Weeks 6 and 16 in MAS Score in the Wrist Flexors of the Study Limb
Week 6
|
-1.3 score on a scale
Standard Deviation 1.1
|
-1.5 score on a scale
Standard Deviation 1.2
|
-1.7 score on a scale
Standard Deviation 1.3
|
|
Mean Change From Baseline to TC 1 Weeks 6 and 16 in MAS Score in the Wrist Flexors of the Study Limb
Week 16
|
-0.9 score on a scale
Standard Deviation 1.2
|
-1.0 score on a scale
Standard Deviation 1.2
|
-1.3 score on a scale
Standard Deviation 1.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (TC 1, Day 1) and TC 1, Weeks 6 and 16.Population: The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with data available at each timepoint and who were injected in the finger flexors are presented.
The MAS was used to assess muscle tone in the upper limb PTMG and consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM) when the affected part is moved in flexion or extension, 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension). The original score '+1' was given a derived numeric score of '2' and the higher numeric scores were incremented by 1 so that the MAS score range was from 0 to 5 with higher scores indicating greater muscle tone. A negative change from baseline indicates a decrease in muscle tone. Data is presented for subjects injected in the finger flexors.
Outcome measures
| Measure |
Dysport 2 U/kg
n=69 Participants
Subjects were randomised to receive Dysport 2 U/kg by IM injection into the study upper limb in TC 1 and Dysport 8 U/kg or 16 U/kg in subsequent TCs (2, 3 and 4).
|
Dysport 8 U/kg
n=69 Participants
Subjects were randomised to receive Dysport 8 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 320 U.
|
Dysport 16 U/kg
n=70 Participants
Subjects were randomised to receive Dysport 16 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 640 U.
|
|---|---|---|---|
|
Mean Change From Baseline to TC 1 Weeks 6 and 16 in MAS Score in the Finger Flexors of the Study Limb
Week 6
|
-0.8 score on a scale
Standard Deviation 0.9
|
-1.8 score on a scale
Standard Deviation 1.1
|
-1.9 score on a scale
Standard Deviation 1.0
|
|
Mean Change From Baseline to TC 1 Weeks 6 and 16 in MAS Score in the Finger Flexors of the Study Limb
Week 16
|
-0.8 score on a scale
Standard Deviation 1.3
|
-1.3 score on a scale
Standard Deviation 0.8
|
-1.8 score on a scale
Standard Deviation 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (TC 1, Day 1) and TC 1, Week 16.Population: The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with available data at the timepoint analysed are presented.
The PGA of treatment response was assessed by asking the investigator the following question: 'How would you rate the response to treatment in the subject's upper limb since the start of the study?'. Answers were on a 9-point rating scale (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved and +4: markedly improved). The mean scores for each treatment group at TC 1 Week 16 are presented.
Outcome measures
| Measure |
Dysport 2 U/kg
n=69 Participants
Subjects were randomised to receive Dysport 2 U/kg by IM injection into the study upper limb in TC 1 and Dysport 8 U/kg or 16 U/kg in subsequent TCs (2, 3 and 4).
|
Dysport 8 U/kg
n=69 Participants
Subjects were randomised to receive Dysport 8 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 320 U.
|
Dysport 16 U/kg
n=70 Participants
Subjects were randomised to receive Dysport 16 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 640 U.
|
|---|---|---|---|
|
Mean PGA Score at TC 1 Week 16
|
1.7 score on a scale
Standard Deviation 1.0
|
1.6 score on a scale
Standard Deviation 1.1
|
1.9 score on a scale
Standard Deviation 1.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (TC 1, Day 1) and TC 1, Week 16.Population: The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with available data at the timepoint analysed are presented.
The GAS is a functional 5-point scale used to measure progress towards individual therapy goals. At start of each TC, 1 to 3 individual goals were defined for each subject by investigator and child's parents/guardians/caregivers prior to treatment. Outcome to reach each goal was rated on a 5-point scale ranging from -2 to +2 (-2: much less than expected outcome, -1: somewhat less than expected outcome, 0: expected outcome, +1: somewhat more than expected outcome, +2: much more than expected outcome). Higher score indicates a better outcome. A GAS T-score was calculated as: 50+(10∑\_(i=1)\^n wi xi)/√(0.7∑\_(i=1)\^n wi\^2 +0.3(∑\_(i=1)\^n wi)\^2) where, xi = rating of ith goal post-baseline; wi = weight of ith goal, calculated as importance \* difficulty as defined at baseline; n = number of goals assessed at baseline and post-baseline. A GAS T-score of 50 indicates goals achieved as expected. Scores below 50 reflect under attainment of goals and scores above 50 reflect over attainment of goals.
Outcome measures
| Measure |
Dysport 2 U/kg
n=69 Participants
Subjects were randomised to receive Dysport 2 U/kg by IM injection into the study upper limb in TC 1 and Dysport 8 U/kg or 16 U/kg in subsequent TCs (2, 3 and 4).
|
Dysport 8 U/kg
n=69 Participants
Subjects were randomised to receive Dysport 8 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 320 U.
|
Dysport 16 U/kg
n=70 Participants
Subjects were randomised to receive Dysport 16 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 640 U.
|
|---|---|---|---|
|
Mean GAS Total Score at TC 1, Week 16
|
54.7 T-score
Standard Deviation 9.8
|
54.2 T-score
Standard Deviation 9.7
|
55.1 T-score
Standard Deviation 10.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (TC 1, Day 1) and TC 1, Week 16.Population: The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects who were assessed at each timepoint are presented.
Parents/guardians completed questionnaires on their child's quality of life. The PedsQL parent inventory measured healthcare concepts for children/adolescents aged 2-18 years. The Generic Core Scales include physical, emotional, social and school aspects. The CP module was also completed. Scores were transformed on a scale from 0 to 100 with higher scores indicating a better quality of life. Mean changes from baseline to TC 1, Week 16 are presented for the General Core Scale and for the CP module. A positive change from baseline indicates an improvement in quality of life.
Outcome measures
| Measure |
Dysport 2 U/kg
n=69 Participants
Subjects were randomised to receive Dysport 2 U/kg by IM injection into the study upper limb in TC 1 and Dysport 8 U/kg or 16 U/kg in subsequent TCs (2, 3 and 4).
|
Dysport 8 U/kg
n=69 Participants
Subjects were randomised to receive Dysport 8 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 320 U.
|
Dysport 16 U/kg
n=70 Participants
Subjects were randomised to receive Dysport 16 U/kg by IM injection into the study upper limb in TC 1 and all subsequent TCs (2, 3 and 4), up to a maximum of 640 U.
|
|---|---|---|---|
|
Mean Change From Baseline to TC 1, Week 16 in the Paediatric Quality of Life (PedsQL) Scores
Generic Core Scale
|
3.4 score on a scale
Standard Deviation 9.7
|
3.4 score on a scale
Standard Deviation 17.1
|
2.0 score on a scale
Standard Deviation 12.0
|
|
Mean Change From Baseline to TC 1, Week 16 in the Paediatric Quality of Life (PedsQL) Scores
CP Module
|
4.8 score on a scale
Standard Deviation 16.8
|
2.1 score on a scale
Standard Deviation 14.9
|
2.8 score on a scale
Standard Deviation 16.2
|
Adverse Events
TC1: Dysport 2 U/kg
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
TC 1: Dysport 8 U/kg
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
TC 1: Dysport 16 U/kg
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
TC 2: Dysport 8 U/kg
Serious events: 6 serious events
Other events: 18 other events
Deaths: 0 deaths
TC 2: Dysport 16 U/kg
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
TC 3: Dysport 8 U/kg
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
TC 3: Dysport 16 U/kg
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
TC 4: Dysport 8 U/kg
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
TC 4: Dysport 16 U/kg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TC1: Dysport 2 U/kg
n=70 participants at risk
Subjects randomised to Dysport 2 U/kg in TC 1.
|
TC 1: Dysport 8 U/kg
n=70 participants at risk
Subjects randomised to Dysport 8 U/kg in TC 1.
|
TC 1: Dysport 16 U/kg
n=70 participants at risk
Subjects randomised to Dysport 16 U/kg in TC 1.
|
TC 2: Dysport 8 U/kg
n=88 participants at risk
Subjects who received Dysport 8 U/kg in TC 2.
|
TC 2: Dysport 16 U/kg
n=90 participants at risk
Subjects who received Dysport 16 U/kg in TC 2.
|
TC 3: Dysport 8 U/kg
n=49 participants at risk
Subjects who received Dysport 8 U/kg in TC 3.
|
TC 3: Dysport 16 U/kg
n=58 participants at risk
Subjects who received Dysport 16 U/kg in TC 3.
|
TC 4: Dysport 8 U/kg
n=22 participants at risk
Subjects who received Dysport 8 U/kg in TC 4.
|
TC 4: Dysport 16 U/kg
n=33 participants at risk
Subjects who received Dysport 16 U/kg in TC 4.
|
|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Epilepsy
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
1.4%
1/70 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
3.4%
2/58 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Nervous system disorders
Focal dyscognitive seizures
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
1.4%
1/70 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Nervous system disorders
Cerebral ventricle dilatation
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
1.4%
1/70 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Nervous system disorders
Seizure
|
1.4%
1/70 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
2.3%
2/88 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
2.0%
1/49 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Psychiatric disorders
Depression
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
1.4%
1/70 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Gastrointestinal disorders
Gastritis
|
1.4%
1/70 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/70 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.4%
1/70 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
1.1%
1/88 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
1.1%
1/88 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
1.1%
1/88 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Infections and infestations
Influenza
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
1.1%
1/88 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular malignant teratoma
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
1.1%
1/90 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
General disorders
Pyrexia
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
1.1%
1/88 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
1.1%
1/88 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
1.1%
1/88 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
1.7%
1/58 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Surgical and medical procedures
Medical device removal
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
2.0%
1/49 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Surgical and medical procedures
Muscle release
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
2.0%
1/49 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Surgical and medical procedures
Ostectomy
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
2.0%
1/49 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Surgical and medical procedures
Radiotherapy to bone
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
2.0%
1/49 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
2.0%
1/49 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Nervous system disorders
Headache
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
3.0%
1/33 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Surgical and medical procedures
Scoliosis surgery
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
Other adverse events
| Measure |
TC1: Dysport 2 U/kg
n=70 participants at risk
Subjects randomised to Dysport 2 U/kg in TC 1.
|
TC 1: Dysport 8 U/kg
n=70 participants at risk
Subjects randomised to Dysport 8 U/kg in TC 1.
|
TC 1: Dysport 16 U/kg
n=70 participants at risk
Subjects randomised to Dysport 16 U/kg in TC 1.
|
TC 2: Dysport 8 U/kg
n=88 participants at risk
Subjects who received Dysport 8 U/kg in TC 2.
|
TC 2: Dysport 16 U/kg
n=90 participants at risk
Subjects who received Dysport 16 U/kg in TC 2.
|
TC 3: Dysport 8 U/kg
n=49 participants at risk
Subjects who received Dysport 8 U/kg in TC 3.
|
TC 3: Dysport 16 U/kg
n=58 participants at risk
Subjects who received Dysport 16 U/kg in TC 3.
|
TC 4: Dysport 8 U/kg
n=22 participants at risk
Subjects who received Dysport 8 U/kg in TC 4.
|
TC 4: Dysport 16 U/kg
n=33 participants at risk
Subjects who received Dysport 16 U/kg in TC 4.
|
|---|---|---|---|---|---|---|---|---|---|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Investigations
Intenational normalised ratio increased
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Infections and infestations
Impetigo
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
14.3%
10/70 • Number of events 13 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
8.6%
6/70 • Number of events 7 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
8.6%
6/70 • Number of events 7 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
8.0%
7/88 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
6.7%
6/90 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
12.2%
6/49 • Number of events 9 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
8.6%
5/58 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
9.1%
3/33 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
5/70 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
8.6%
6/70 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
11.4%
8/70 • Number of events 10 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
5.7%
5/88 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.4%
4/90 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Infections and infestations
Pharyngitis
|
8.6%
6/70 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.3%
3/70 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
5.7%
4/70 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
8.2%
4/49 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
3.4%
2/58 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
2.0%
1/49 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
5.2%
3/58 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
6.1%
2/33 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Infections and infestations
Ear infection
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
3.0%
1/33 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
3.0%
1/33 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
3.0%
1/33 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Infections and infestations
Viral infection
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.4%
1/70 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.3%
3/70 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
5.7%
4/70 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
5.6%
5/90 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
General disorders
Pyrexia
|
2.9%
2/70 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
5.7%
4/70 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
2.9%
2/70 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
8.0%
7/88 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
1.1%
1/90 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
General disorders
Injection site bruising
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
General disorders
Injection site rash
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
7.1%
5/70 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
1.4%
1/70 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
1.1%
1/88 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
1.1%
1/90 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Nervous system disorders
Headache
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
5.7%
4/70 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
2.9%
2/70 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
1.1%
1/88 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
6.1%
3/49 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
3.4%
2/58 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/22 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/70 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/88 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/90 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/49 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/58 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
4.5%
1/22 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
0.00%
0/33 • Treatment emergent adverse events (TEAEs) were collected from the first injection of study treatment up to the end of TC 4 (up to 21 months).
TEAEs are reported for the dose received prior to onset of the AE. Due to dose adaption due to safety lower doses were permitted for TCs 2 - 4.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place